SecProbe.io

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 September 24, 2025

Pierre Gravier
Chief Financial Officer
PTC Therapeutics, Inc.
500 Warren Corporate Center Drive
Warren, NJ 07059

 Re: PTC Therapeutics, Inc.
 Form 10-K for Fiscal Year Ended December 31, 2024
 Filed February 27, 2025
 File No. 001-35969
Dear Pierre Gravier:

 We have completed our review of your filing. We remind you that the
company and
its management are responsible for the accuracy and adequacy of their
disclosures,
notwithstanding any review, comments, action or absence of action by the staff.

 Sincerely,

 Division of Corporation
Finance
 Office of Life Sciences
</TEXT>
</DOCUMENT>

CORRESP
 1
 filename1.htm

 ​ ​ ​ ​ ​ PTC Therapeutics, Inc. 500 Warren Corporate Center Drive Warren, NJ 07059 www.ptcbio.com ​ September 18, 2025 Ms. Christine Torney Ms. Vanessa Robertson Mr. Daniel Crawford Mr. Chris Edwards Office of Life Sciences United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re:    PTC Therapeutics, Inc. Form 10-K for the Fiscal Year Ended December 31, 2024 Filed February 27, 2025 File No. 001-35969 ​ ​ Dear Ms. Torney, Ms. Robertson, Mr. Crawford and Mr. Edwards: This letter is submitted on behalf of PTC Therapeutics, Inc. (the “Company” or “PTC”) in response to written comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the letter dated August 21, 2025 with respect to PTC’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the Commission on February 27, 2025 (the “2024 Form 10-K”). The Staff’s comments are reproduced below and the Company’s corresponding responses follow accordingly. Form 10-K for the Fiscal Year Ended December 31, 2024 Item 1. Business Our Collaboration License Agreements and Funding Arrangements National Taiwan University, page 24 1. Please revise in subsequent filings to disclose the sales royalty percentage to a range within 10 percentage points pursuant to the NTU Licensing Agreement. Response: The Company confirms that in subsequent filings it will disclose the sales royalty percentage to a range within 10 percentage points pursuant to the NTU Licensing Agreement . 1 The following paragraph, with an updated narrative for the fiscal year ended December 31, 2024, reflects how PTC plans to enhance its disclosures in its subsequent filings: Funding Obligations.   NTU received a lump sum of $100,000 upon execution of the NTU Licensing Agreement, as well as $2.0 million milestones payments based on the achievement of certain clinical and regulatory milestones, including $1.2 million that became due and payable in July 2022 upon the EC’s approval of Upstaza for the treatment of AADC deficiency. Additionally, NTU will be entitled to receive contingent payments from us based on (i) annual license maintenance fees, (ii) a low double-digit percentage royalty of annual net sales between 10% and 15% of Licensed Products, and (iii) a percentage of sublicense revenue, ranging from low-twenties to mid-twenties. The annual license maintenance fees are non-refundable, but creditable against annual net sales payments. Shiratori, page 26 2. Please revise future filings to disclose the total aggregate amount of milestone payments made to date and maybe be paid in the future pursuant to the Shiratori License Agreement. Response: The Company notes that the aggregate amount obligated to Shiratori for regulatory and development milestones is approximately $1.0 million and considered immaterial to the Company. The Company confirms that in its future filings, it will disclose it as such. The following paragraph, with an updated narrative for the fiscal year ended December 31, 2024, reflects how PTC plans to enhance its disclosures in its future filings: Payments and Contingent Payments. Under the Shiratori License Agreement, we are obligated to pay to Shiratori a low single digit percentage of annual net sales of the Sepiapterin Products in each country in the Sepiapterin Territory until the expiration of the last-to-expire Licensed Patent controlled by Shiratori covering the relevant country followed by an obligation to pay a reduced royalty rate for a specified period of time thereafter. We are also obligated to pay Shiratori certain regulatory and development milestones that are of an immaterial amount. Intellectual Property Patents and trade secrets, page 28 3. We note your disclosure on page 29 that composition of matter patents related to ataluren expired in 2024 and its patents related to therapeutic methods are set to expire in 2026 and 2027. We also note your disclosure on page 30 that patents related to vatiquinone will begin expiring in 2026. In future filings, please expand your risk factor disclosure to discuss specific risks that may result based on ataluren and vatiquinone’s imminent patent expiration. Response: The Company confirms that in future filings it will expand its risk factor disclosure to discuss specific risks that may result based on ataluren and vatiquinone’s imminent patent expiration. 2 The following risk factor, with an updated narrative for the fiscal year ended December 31, 2024, reflects how PTC plans to enhance its disclosures in its future filings: If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection is not sufficiently broad, and at such times as our patent protection expires, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be adversely affected. Our success depends in large part on our ability to obtain and maintain patent protection or other intellectual property rights with respect to our proprietary technology and products. One primary way that we seek to protect our proprietary position is by filing patent applications in the United States and in certain ex-U.S. jurisdictions related to our proprietary technology and products. This process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications. It is also possible that we will fail to file a patent application on patentable aspects of our research and development. Moreover, if we license technology or product candidates from third parties, these license agreements may not permit us to control the filing and prosecution of patent applications, or to maintain or enforce the patents. These agreements could also give our licensors the right to enforce the licensed patents without our involvement, or to decide not to enforce the patents at all. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the commercial value of our patent rights is highly uncertain. Our pending and future patent applications may not result in patents being issued which prevent others from commercializing competitive technologies and products. Changes in patent laws or their interpretation in the United States and other countries may diminish the value of our patents. The laws of ex-U.S. countries may not protect our rights to the same extent as the laws of the United States. For example, patent law in many countries restricts the patentability of methods of treatment of the human body more than U.S. law does. In addition, we may not pursue or obtain or be able to pursue or obtain patent protection in all major markets. Assuming the other requirements for patentability are met, currently, the first to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in the United States, the first to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions. In addition, the Leahy-Smith America Invents Act of 2011, or the Act, which reformed certain patent laws in the U.S., may create additional uncertainty. The significant changes engendered by the Act include switching from a “first-to-invent” system to a “first-to-file” system, and the implementation of new procedures that permit competitors 3 to challenge our patents in the USPTO after grant, including inter partes review and post grant review. Moreover, we may be subject to a third-party prior art submissions in a patent office, or may become involved in patent office proceedings, including oppositions, derivation proceedings, reexamination, inter partes review, post grant review, interference proceedings, or litigation, in the United States or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us. Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection or prevent competitors from competing with us. Our competitors may be able to circumvent our owned or licensed patents by developing alternative technologies or products in a non-infringing manner. Other companies may also attempt to circumvent any regulatory data protection or market exclusivity that we obtain under applicable legislation, which may require us to allocate significant resources to prevent such circumvention. Legal and regulatory developments in the European Union, or EU, and elsewhere may also result in clinical trial data and other information, that would ordinarily be treated as trade secret, submitted as part of a marketing authorization application becoming publicly available. The EMA Policy on publication of clinical data and other such information, as well as the current application of EU freedom of information regulations, could impact our proprietary information (comprising both clinical and non-clinical data and other information) that would normally be maintained by a regulatory body as commercially confidential. Such developments could enable other companies to circumvent our intellectual property rights and use our clinical trial data or other information to obtain marketing authorizations in the EU and in other jurisdictions where we have not been able to obtain any intellectual property or regulatory protection, resulting in loss of market share. Such developments may also require us to allocate significant resources or engage in litigation to prevent other companies from circumventing or violating our intellectual property rights. Our attempts to prevent third parties from circumventing or violating our intellectual property and other rights may ultimately be unsuccessful. We may also fail to take the required actions to maintain our patents. For example, during 2015, we were notified by the EMA that it had received from another pharmaceutical company a request under Regulation (EC) No 1049/2001 seeking access to aspects of our marketing authorization for Translarna for the treatment of nmDMD. Following the decision of the EMA to release such documentation with only minimal redactions we initiated litigation before the General Court of the EU to prevent disclosure of this information. In the first quarter of 2018, the Court ruled in favor of the EMA, allowing the EMA to release the documentation. We appealed the General Court’s decision to the Court of Justice of the EU, or CJEU, but the CJEU dismissed our appeal in January 2020 and released the information to the requester. 4 All patents have expiration dates and, to the extent that we are able to obtain and maintain patents, such patents will only provide protection to us until they expire. Certain of our patents have expired and we have additional patents that will expire over the next three years. For ataluren, the issued U.S. patents relating to composition of matter expired in 2024 and issued U.S. patents relating to therapeutic methods of use, drug substance and drug product are currently scheduled to expire in 2027, including patent term adjustment. Granted European patents drawn to composition of matter of ataluren expired in 2024; patents covering dosage regimens of ataluren will expire in 2026 and patents covering the drug substance will expire in 2027; and patents drawn to the manufacturing process for ataluren will expire in 2027. For vatiquinone, granted European patents drawn to composition of matter and to methods of use will expire in 2026. As a result of the expiration of our composition of matter patents for ataluren, other companies are, subject to our other patents, no longer restricted in their ability to develop products utilizing the expired patented subject matter in the applicable jurisdictions, which could include products that compete with ataluren. Similarly, upon the impending expiration of our other patents for ataluren and vatiquinone described above, other companies will no longer be restricted in their ability to utilize the expired patented subject matter to develop competing therapies in the applicable jurisdictions. An issued patent may be challenged, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Management’s Discussion and Analysis of Financial Condition and Results of Operations Financial operations overview Research and development expense, page 122 4. You disclose that you track expenses related to your clinical programs and certain preclinical programs on a per project basis. Please provide revised disclosure to be included in future filings to break out the ‘Development’ line item by program. Response: The Company confirms that in future filings it will expand our disclosure to break out the ‘Development’ line item by program. 5 The following table, with updated disclosure for the fiscal year ended December 31, 2024, reflect how PTC plans to enhance its disclosures in its future filings: The following table provides research and development expense for our most advanced principal product development programs, for the years ended December 31, 2024, 2023, and 2022. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, ​      2024      2023      2022 ​ ​ (in thousands) Global DMD ​ $ 27,758 ​ $ 45,387 ​ $ 50,020 Gene therapy ​ ​ 17,339 ​ ​ 42,114 ​ ​ 66,199 Sepiapterin ​ ​ 96,043 ​ ​ 94,031 ​ ​ 80,989 Splicing platform ​ ​ 25,225 ​ ​ 22,576 ​ ​ 21,122 Inflammation & Ferroptosis platform ​ ​ 49,277 ​ ​ 52,154 ​ ​ 59,552 Other development programs ​ ​ 3,952 ​ ​ 24,873 ​ ​ 26,234 Total Development ​ ​ 219,594 ​ ​ 281,134 ​ ​ 304,116 Research ​ ​ 63,375 ​ ​ 99,286 ​ ​ 115,159 Milestones ​ ​ 65,000 ​ ​ 30,000 ​ ​ — Payroll, benefits & share-based compensation expense ​ ​ 147,052 ​ ​ 205,359 ​ ​ 188,751 Facilities and other indirect costs ​ ​ 39,459 ​ ​ 50,783 ​ ​ 43,470 Total research and development ​ $ 534,480 ​ $ 666,563 ​ $ 651,496 ​ * * * ​ ​ 6 Tha

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<TYPE>TEXT-EXTRACT
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<FILENAME>filename2.txt
<TEXT>
 August 21, 2025

Pierre Gravier
Chief Financial Officer
PTC Therapeutics, Inc.
500 Warren Corporate Center Drive
Warren, NJ 07059

 Re: PTC Therapeutics, Inc.
 Form 10-K for Fiscal Year Ended December 31, 2024
 Filed February 27, 2025
 File No. 001-35969
Dear Pierre Gravier:

 We have reviewed your filing and have the following comments.

 Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.

 After reviewing your response to this letter, we may have additional
comments.

Form 10-K for Fiscal Year Ended December 31, 2024
Item 1. Business
Our Collaborations, License Agreements and Funding Arrangements
National Taiwan University, page 24

1. Please revise in subsequent filings to disclose the sales royalty
percentage to a range
 within 10 percentage points pursuant to the NTU Licensing Agreement.
Shiratori, page 26

2. Please revise future filings to disclose the total aggregate amount of
milestone
 payments made to date and may be paid in the future pursuant to the
Shiratori License
 Agreement.
Intellectual Property
Patents and trade secrets, page 28

3. We note your disclosure on page 29 that composition of matter patents
related to
 ataluren expired in 2024 and its patents related to therapeutic methods
are set to expire
 August 21, 2025
Page 2

 in 2026 and 2027. We also note your disclosure on page 30 that patents
related to
 vaquinone will begin expiring in 2026. In future filings, please expand
your risk factor
 disclosure to discuss specific risks that may result based on ataluren
and vaquinone s
 imminent patent expirations.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Financial operations overview
Research and development expense, page 122

4. You disclose that you track expenses related to your clinical programs
and certain
 preclinical programs on a per project basis. Please provide revised
disclosure to be
 included in future filings to break out the 'Development' line item by
program.
 We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence
of action by the staff.

 Please contact Christine Torney at 202-551-3652 or Vanessa Robertson at
202-551-
3649 if you have questions regarding comments on the financial statements and
related
matters. Please contact Daniel Crawford at 202-551-7767 or Chris Edwards at
202-551-6761
with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
</TEXT>
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United States securities and exchange commission logo
October 27, 2021
Emily Hill
Chief Financial Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ 07080
Re:PTC Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 25, 2021
File No. 001-35969
Dear Ms. Hill:
            We have completed our review of your filings.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
1
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October 19, 2021

Mr. Gary
Newberry

Ms. Mary
Mast

Office of Life Sciences

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

    Re:

    PTC Therapeutics, Inc.

    Form 10-K for the Fiscal Year Ended December 31, 2020

    Response dated September 23, 2021

    File No. 001-35969

Dear Mr. Newberry
and Ms. Mast:

This letter is submitted
on behalf of PTC Therapeutics, Inc. (the “Company” or “PTC”) in response to written comments of the Staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the letter dated October 6,
2021 with respect to the Company’s response dated September 23, 2021 to the Staff’s letter dated August 26, 2021
with respect to PTC’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the Commission
on February 25, 2021 (the “2020 Form 10-K”). The Staff’s comment is reproduced below and the Company’s
corresponding response follows accordingly.

Form 10-K for the Fiscal Year Ended December 31,
2020

Management’s Discussion and Analysis

Results of Operations for the years
ended December 31, 2020 and 2019

Net product revenue, page 153

 1. We acknowledge your response to comment number 1, but respectively believe that disclosure of product
revenue by each significant product would be useful information for an investor, even if there are only two products. Please confirm that
you will provide disclosure in future filings. To the extent that one of the products is not generating significant product revenue, please
state that fact. Also, revise to provide disaggregated information by product in your financial statements pursuant to ASC 606-10-55-89
through 55-91 or tell us how you have met the disclosure requirements.

Response:
The Company confirms that in future filings it will disclose the product revenue of each significant product in the narrative
of the “Net product revenue” subsection of “Management’s Discussion and Analysis”.

The following paragraph, with an updated narrative
for the fiscal year ended December 31, 2020, reflects how PTC plans to enhance its disclosures in its future filings:

Net
product revenues. Net product revenue was $333.4 million for the year ended December 31, 2020, an increase of $42.1
million, or 14%, from net product revenue of $291.3 million for the year ended December 31, 2019, primarily stemming from net
product sales of Translarna and Emflaza. Translarna net product revenue was $191.9 million for the year ended December 31, 2020,
an increase of $1.9 million, or 1%, compared to $190.0 million for the year ended December 31, 2019. These results were
driven by broader uptake due to new patients in existing geographies, geographic expansion, and label updates. Emflaza net product
revenue was $139.0 million for the year ended December 31, 2020, an increase of $38.0 million, or 38%, compared to $101.0 million
for the year ended December 31, 2019. The increase was primarily due to the increase of
new patient prescriptions and higher patient compliance.

Additionally,
the Company confirms that in future filings it will revise its disclosure in its financial statements to provide disaggregated information
by product pursuant to ASC 606-10-55-89 through 55-91.

The following paragraphs, with an updated footnote
13 “Revenue Recognition” for fiscal year ended December 31, 2020, reflects how PTC plans to enhance its disclosures in
its future filings:

The Company views its operations and
manages its business in one operating segment.

During
the twelve months ended December 31, 2020, 2019, and 2018, net product sales in the United States were $139.0 million,
$101.0 million, and $92.0 million respectively, consisting solely of sales of Emflaza, and net product sales outside the United
States were $194.4 million, $190.3 million, and $171.0 million respectively, consisting of sales of Translarna, Tegsedi,
and Waylivra. Translarna net product revenues made up $191.9 million, $190.0 million and $171.0 million of the net product sales
outside the United States for the twelve months ended December 31, 2020, 2019 and 2018, respectively. For the twelve months ended
December 31, 2020 and 2019, two of the Company’s distributors each accounted for over 10% of the Company’s
net product sales. For the twelve months ended December 31, 2018, three of the Company’s distributors each accounted
for over 10% of the Company’s net product sales.

* * *

Thank
you for your consideration of our response to your comments. Should the Staff have additional questions or comments regarding the
foregoing, please do not hesitate to contact the undersigned at (908) 912-9327.

    Sincerely,

    PTC Therapeutics, Inc.

    /s/ Emily Hill

    Emily Hill

    Chief Financial Officer

United States securities and exchange commission logo
October 6, 2021
Emily Hill
Chief Financial Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ 07080
Re:PTC Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Response dated September 23, 2021
File No. 001-35969
Dear Ms. Hill:
            We have reviewed your September 23, 2021 response to our comment letter and have the
following comments.  In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional
comments.  Unless we note otherwise, our references to prior comments are to comments in our
August 26, 2021 letter.
Form 10-K for the Fiscal Year Ended December 31, 2020
Management's Discussion and Analysis
Results of Operations for the years ended December 31, 2020 and 2019
Net Product Revenue, page 153
1.We acknowledge your response to comment number 1, but respectively believe that
disclosure of product revenue by each significant product would be useful information for
an investor, even if there are only two products. Please confirm that you will provide
disclosure in future filings. To the extent that one of the products is not generating
significant product revenue, please state that fact. Also, revise to provide disaggregated
information by product in your financial statements pursuant to ASC 606-10-55-89
through 55-91 or tell us how you have met the disclosure requirements.

 FirstName LastNameEmily Hill
 Comapany NamePTC Therapeutics, Inc.
 October 6, 2021 Page 2
 FirstName LastName
Emily Hill
PTC Therapeutics, Inc.
October 6, 2021
Page 2
            You may contact Gary Newberry at (202) 551-3761 or Mary Mast, Senior Accountant, at
(202) 551-3613 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
1
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September 23, 2021

Mr. Gary Newberry

Ms. Mary Mast

Office of Life Sciences

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

    Re:

    PTC Therapeutics, Inc.

    Form 10-K for the Fiscal Year Ended December 31, 2020

    Filed February 25, 2021

    File No. 001-35969

Dear Mr. Newberry
and Ms. Mast:

This letter is submitted
on behalf of PTC Therapeutics, Inc. (the “Company” or “PTC”) in response to written comments of the Staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the letter dated August 26,
2021 with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with
the Commission on February 25, 2021 (the “2020 Form 10-K”). The Staff’s comments are reproduced below and
the Company’s corresponding responses follow accordingly.

Form 10-K for the Fiscal Year Ended December 31,
2020

Net product revenue, page 153

 1. Quantify in future filings the changes in each significant product and discuss the reason for the
changes. Consider including a table of product revenue by product that is reconciled to Net product revenue on the face of the financial
statements.

Response: The Company confirms that in
future filings it will specifically quantify the changes in revenue for each significant product and will discuss the reason for the changes.
The Company notes that some of this information is already contained in the 2020 Form 10-K, including the reason for changes in net
product revenue. The Company proposes that going forward in the referenced section, it will disclose the year over year changes, and reason
for such change, for overall product revenue as well as broken out for each significant product. The Company will consider including a
table of product revenue by product, once it has additional significant products such that a table would be useful. At this time, with
only two significant products, the Company believes that such a table would be of minimal incremental benefit.

Notes to consolidated financial statements

2. Summary of
significant accounting policies

Segment and
geographic information, page 179

 2. Please disclose in future filings the geographic revenue information required by ASC 280-10-50-41
or tell us why the disclosure is not required. In this regard, we note the disclosure of U.S. product sales on page 217, but the
remaining revenue is not broken down by country.

Response: The
Company advises the Staff that, pursuant to ASC 280-10-50-41, the Company included in the 2020 Form 10-K disclosure of revenues from
external customers for its country of domicile and for those attributable to all other countries in total. The Company agrees that, if
material, separate disclosure is required for each individual foreign country under ASC 280-10-50-41. For fiscal year 2020, the Company
did not consider the revenue of any individual foreign country to be material and therefore did not provide further breakdown by country.
However, if, in future years, the Company deems the revenue of any individual foreign country material, it will provide the necessary
disclosure as required.

6. Leases, page 203

 3. You state that on June 19, 2020 you entered into a commercial manufacturing service agreement
for a term of 12.5 years for which you concluded the agreement contains an embedded lease. You also state that given the embedded finance
lease is designed for the production of PTC’s AADC program and would not have an alternate use outside the PTC gene therapy platform
you determined the lease should be treated as research and development expense under ASC 730. Accordingly, you expensed the present value
of all guaranteed future cash payments of $41.4 million in 2020. Please tell us and disclose in future filings the following:

 · Provide us an analysis of the basis for your accounting treatment under ASC 842.

 · Clarify if the $41.4 million was expensed as research and development or recorded as a Right-of-Use
Asset (ROU) as referenced on page 204.

 · If the $41.4 million is included as a ROU asset on your balance sheet, please tell us where the
amount is presented.

 · Clarify if the Finance lease liability on the balance sheet relates to the manufacturing service
agreement.

 · If the $41.4 million is determined to be properly accounted for as a research and development expense,
tell us why recognition in the current year, instead of over the term of the agreement is appropriate.

Response:

PTC entered into a Commercial Manufacturing Service
agreement (the “Agreement”) with the University of Massachusetts (“MassBio” or “MassBiologics”) on
June 19, 2020. PTC determined that the Agreement included an embedded lease. The Agreement identifies certain manufacturing rooms
of the SouthCoast Facility as PTC’s dedicated space. PTC determined the lease of the dedicated space commenced as of the execution
of the Agreement on June 19, 2020 for a term of 12.5 years through December 31, 2032.

PTC benefits directly from the dedicated space,
which is the lease component, and the right of use is highly dependent on other services / rights in the Agreement, which are non-lease
components. As disclosed in Footnote 2, Summary of significant accounting policies, of the 2020 Form 10-K, PTC accounts for the lease
component and the associated non-lease components as a single component under Accounting Standards Codification (ASC), Leases, 842-10-15-37.
Finally, the present value of the sum of the lease payments was determined to exceed the fair value (as determined by a third-party valuation
firm) of the underlying lease assets associated with the contractual agreement, as such, the finance lease criteria was met. PTC initially
recognized a finance ROU asset and finance lease liability in accordance with ASC 842.

PTC evaluated the leased asset which is designed
for the production of PTC’s AADC program and determined that the ROU assets would not have an alternate use outside the PTC gene
therapy platform without incurring significant costs and modifications to the contract with MassBio. Per ASC 730, the costs of materials,
equipment, or facilities that are acquired or constructed for a particular R&D project and that have no alternative future uses (in
other R&D projects or otherwise) and therefore no separate economic values are R&D costs at the time the costs are incurred. There
is often a high degree of uncertainty about whether R&D expenditures will provide any future benefits. ASC 730 states the general
lack of discernible future benefits at the time R&D costs are incurred indicates that the immediate recognition principle of expense
recognition should apply. As such, PTC evaluated ASC 730, determined that the lease should be treated as research and development expense
and expensed the $41.4 million ROU assets in fiscal year 2020. The finance lease liability did not change as a result of the accounting
treatment for ASC 730.

Finally, PTC confirms that the finance lease liability
on the balance sheet relates to the Mass Bio contract and will clarify its disclosures in the future to make it clear that the liability
relates to that Agreement.

The following is a portion of PTC’s prior
year end lease disclosure updated to show how PTC plans to enhance our disclosures in our future filings:

On June 19, 2020, the Company entered into
a commercial manufacturing service agreement for a term of 12.5 years with MassBiologics of the University of Massachusetts Medical School
("MassBio"). The agreement will expire on December 31, 2032 unless the Company terminates it with 24 months prior written
notice to MassBio. Pursuant to the terms of the agreement, MassBio agreed to provide the Company with certain dedicated space for its
gene therapy AADC program. The Company concluded that the agreement contains an embedded lease as the Company controls the use of the
four dedicated rooms and the equipment therein. The agreement included guaranteed lease payments of $15.0 million at the onset of the
agreement and $3.0 million annually thereafter. The present value of the guaranteed lease payments was determined to be $41.4 million,
which exceeded the assessed fair value of the Company’s share of the building. Therefore, the Company determined that the agreement
was a finance lease, for which the Company recorded a finance lease ROU asset and corresponding finance lease liability at the onset of
the lease agreement. Given that the leased asset is designed for the production of PTC’s AADC program and would not have an alternate
use outside the PTC gene therapy platform without incurring significant costs, the Company determined that the lease should be treated
as research and development expense under ASC 730. Accordingly, the full $41.4 million relating to the finance lease ROU asset was written
off and expensed to research and development during the year ending December 31, 2020. The remaining balance for the finance lease
ROU asset related to this arrangement is $0 as of December 31, 2020. As of December 31, 2020, the balance of the finance lease
liabilities- current and finance lease liabilities- non-current are $1.3 million and $23.1 million, respectively, and are directly related
to the Company’s MassBio agreement. Additionally, during the year ending December 31, 2020, the Company recorded finance lease
costs of $0.9 million related to interest on the lease liability.

* * *

Thank you for your consideration
of our response to your comments. Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate
to contact the undersigned at (908) 912-9327.

    Sincerely,

    PTC Therapeutics, Inc.

    /s/
    Emily Hill

    Emily Hill

    Chief Financial Officer

United States securities and exchange commission logo
August 26, 2021
Emily Hill
Chief Financial Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ 07080
Re:PTC Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 25, 2021
File No. 001-35969
Dear Ms. Hill:
            We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.  In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2020
Net product revenue, page 153
1.Quantify in future filings the changes in each significant product and discuss the reason
for the changes. Consider including a table of product revenue by product that is
reconciled to Net product revenue on the face of the financial statements.
Notes to the consolidated financial statements
2. Summary of significant accounting policies
Segment and geographic information, page 179
2.Please disclose in future filings the geographic revenue information required by ASC 280-
10-50-41 or tell us why the disclosure is not required. In this regard, we note the
disclosure of U.S. product sales on page 217, but the remaining revenue is not broken
down by country.

 FirstName LastNameEmily Hill
 Comapany NamePTC Therapeutics, Inc.
 August 26, 2021 Page 2
 FirstName LastName
Emily Hill
PTC Therapeutics, Inc.
August 26, 2021
Page 2
6. Leases, page 203
3.You state that on June 19, 2020 you entered into a commercial manufacturing service
agreement for a term of 12.5 years for which you concluded the agreement contains an
embedded lease. You also state that given the embedded finance lease is designed for the
production of PTC's AADC program and would not have an alternate use outside the PTC
gene therapy platform you determined the lease should be treated as research and
development expense under ASC 730. Accordingly, you expensed the present value of all
guaranteed future cash payments of $41.4 million in 2020. Please tell us and disclose in
future filings the following:

•Provide us an analysis of the basis for your accounting treatment under ASC 842.
•Clarify if the $41.4 million was expensed as research and development or recorded as
a Right-of-Use Asset (ROU) as referenced on page 204.
•If the $41.4 million is included as a ROU asset on your balance sheet, please tell us
where the amount is presented.
•Clarify if the Finance lease liability on the balance sheet relates to the manufacturing
service agreement.
•If the $41.4 million is determined to be properly accounted for as research and
development expense, tell us why recognition in the current year, instead of over the
term of the agreement is appropriate.

            In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
            You may contact Gary Newberry at (202) 551-3761 or Mary Mast, Senior Staff
Accountant, at (202) 551-3613 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

October 18, 2019
Emily Hill
Chief Financial Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ 07080
Re:PTC Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 1, 2019
File No. 001-35969
Dear Ms. Hill:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
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October 9, 2019

Mr. Mark Brunhofer

Ms. Sharon Blume

Office of Healthcare & Insurance

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

Re:                             PTC Therapeutics, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2018

Filed March 1, 2019

File No. 001-35969

Dear Mr. Brunhofer and Ms. Blume:

This letter is submitted on behalf of PTC Therapeutics, Inc. (the “Company” or “PTC”) in response to a written comment of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the letter dated September 26, 2019 (the “Comment Letter”) with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as filed with the Commission on March 1, 2019 (the “2018 Form 10-K”). The Staff’s comment is reproduced below and the Company’s corresponding response follows accordingly.

Form 10-K for the Fiscal Year Ended December 31, 2018

Notes to consolidated financial statements

Note 13: Income taxes, page 171

1.              On page 173 you disclose that the deferred tax liability associated with the in-process research and development intangible asset from your acquisition of Agilis Biotherapeutics, Inc. is not considered positive evidence of future income in part because it is an indefinite-lived intangible asset.  Please tell us why you did not record some income tax benefit outside acquisition accounting under ASC 805-740-30-3 associated with any net operating loss generated in 2018.  In this regard, we note that net operating losses since the enactment of the Tax Cuts and Jobs Act do not expire.  In your response, tell us the amount of net operating loss generated in 2018.  Reference for us the authoritative literature you rely upon to support your accounting.

Response:

The Company acknowledges the guidance in ASC 805-740-30-3 which notes that an acquirer may be able to utilize the benefit of its tax operating loss carryforwards against the future taxable profit of the acquiree and reduce its valuation allowance based on the weight of available evidence.  This should be accounted for as an event separate from the business combination; recognized as an element of the acquirer’s deferred income tax expense (benefit) in the reporting period that includes the business combination. However, since the Company generated taxable income for U.S. tax purposes in 2018 of $5.8 million, and as such did not generate any net operating losses in 2018, the Company does not believe this guidance is applicable since the Company does not have any net operating loss carryforwards since the enactment of the 2017 Tax Cuts and Jobs Act to utilize. As a result, the Company did not record any income tax benefit outside of the acquisition.

*  *  *

Thank you for your consideration of our response to your comments. Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (908) 912-9327.

Sincerely,

PTC Therapeutics, Inc.

/s/   Emily Hill

Emily   Hill

Chief   Financial Officer

September 26, 2019
Emily Hill
Chief Financial Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ 07080
Re:PTC Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 1, 2019
File No. 001-35969
Dear Ms. Hill:
            We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.  In our comment, we ask you to provide us with
information so we may better understand your disclosure.
            Please respond to this comment within 10 business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
Notes to consolidated financial statements
Note 13: Income taxes, page 171
1.On page 173 you disclose that the deferred tax liability associated with the in-process
research and development intangible asset from your acquisition of Agilis
Biotherapeutics, Inc. is not considered positive evidence of future income in part because
it is an indefinite-lived intangible asset.  Please tell us why you did not record some
income tax benefit outside acquisition accounting under ASC 805-740-30-3 associated
with any net operating loss generated in 2018.  In this regard, we note that net operating
losses since the enactment of the Tax Cuts and Jobs Act do not expire.  In your response,
tell us the amount of net operating loss generated in 2018.  Reference for us the
authoritative literature you rely upon to support your accounting.
            In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or

 FirstName LastNameEmily Hill
 Comapany NamePTC Therapeutics, Inc.
 September 26, 2019 Page 2
 FirstName LastName
Emily Hill
PTC Therapeutics, Inc.
September 26, 2019
Page 2
absence of action by the staff.
            You may contact Mark Brunhofer at (202) 551-3638 or Sharon Blume at (202) 551-
3474 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance

Mail Stop 4720

February 19, 201 6

Via E -mail
Mr. Shane Kovacs
Chief Financial  Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, New Jersey 07080

Re: PTC Therapeutics, Inc.
 Form 10-K for the Fiscal Year Ended December  31, 201 4
Filed March 2 , 2015
File No. 001-35969

Dear Mr. Kovacs :

We have completed our review of your filing.  We remind you that our comments  or
changes to disclosu re in response to our comments  do not foreclose the Commission from taking
any action with respect to the company or the filing and the compa ny may not assert staff
comments  as a defense in any proceeding initiated by the Commission or any person under the
feder al securities laws of the United States .  We urge all persons who are responsible for the
accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the
information the Securities Exchange Act of 1934 and all applicable ru les require.

Sincerely,

/s/ Sharon M. Blume

Sharon M. Blume
Accounting Branch Chief
Office of Healthcare and Insurance

CORRESP
1
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February 12, 2016

FOIA CONFIDENTIAL TREATMENT REQUEST

The entity requesting confidential treatment is:

PTC Therapeutics, Inc.

100 Corporate Court

South Plainfield, NJ 07080

Attn: Shane Kovacs, Executive Vice President, Chief Financial Officer and

Head of Corporate Development

908-222-7000

BY EDGAR:

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Mail Stop 4720

Washington, D.C. 20549

Attention: Jim B. Rosenberg

Re:                 PTC Therapeutics, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2014

Filed March 2, 2015

Form 10-Q for the Quarterly Period Ended September 30, 2015

Filed November 9, 2015

File No. 001-35969

Ladies and Gentlemen:

This letter is submitted on behalf of PTC Therapeutics, Inc. (the “Company”) in response to our February 5, 2016 phone conversation with the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) as a supplement to the letter filed by us on January 21, 2016 in response to written comments of the Staff of the Commission in the letter dated December 15, 2015 (the “Comment Letter”) from the Staff with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as filed with the Commission on March 2, 2015 (the “2014 Form 10-K”), and the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2015, as filed with the Commission on November 9, 2015 (the “2015 Third Quarter Form 10-Q”). The Staff’s further comment is reproduced below and the Company’s corresponding response follows accordingly.

1

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Critical accounting policies and significant judgments and estimates

Inventories and Cost of Product Revenues, page 100

1.              We acknowledge your response to prior comment 2.  Please clarify for us why you do not capitalize any manufacturing and finishing costs for Translarna product intended for commercial sale under the conditional approval in Europe. Please address the following:

·                  Tell us why the ongoing uncertainty associated with the conditional approval as indicated in the last paragraph of the third page of your response is relevant to your accounting, explaining how expensing inventory costs is consistent with the requirement to carry inventory at the lower of cost or market as required by ASC 330-10-35.

·                  Tell us the amount of your product manufacturing costs incurred in the first nine months of 2015 and the period from conditional approval through the end of 2014 that relate to Translarna manufacturing for commercial supply. Ensure that this amount does not include the finishing costs you provide in the last paragraph of the third page of your response.

·                  Explain why it is appropriate to record any manufacturing costs associated with product sold commercially as R&D expense regardless of materiality.

Response to Comment No. 1

TranslarnaTM (ataluren or PTC124), which is our most advanced product candidate, has been in development in various forms since 1998.  Based on its understood mechanism of action, Translarna may have benefit in the treatment of patients with any genetic disorder that arises as a result of a nonsense mutation. We are currently pursuing Translarna as a treatment for five indications, the most advanced of which is Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy, or nmDMD.  However, we are also pursuing clinical development of Translarna for cystic fibrosis, MPS I, aniridia and genetically defined epilepsy, and we intend to commence clinical trials in additional indications over the next several years.  As of January 16, 2016, Translarna has been manufactured and is being supplied for ongoing clinical studies in which approximately 700 patients or healthy volunteers are enrolled and for approximately 200 patients receiving Translarna on a commercial basis.

In 2010, we announced the results of our Phase 2b 48-week, 174-patient, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Translarna in patients with nmDMD.  We did not achieve the primary efficacy endpoint in the Phase 2b trial with the pre-specified level of statistical significance. In 2013, we initiated a Phase 3 48-week, 228-patient, double-blind, placebo-controlled, clinical trial to evaluate the efficacy and safety of Translarna in nmDMD patients. We refer to this Phase 3 trial as ACT DMD. In October 2015, we announced that we did not achieve the primary efficacy endpoint with the pre-specified level of statistical significance in the ACT DMD trial.

In 2011, we had submitted a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for approval of Translarna for the treatment of nmDMD, primarily based on our post-hoc analysis of the results of our Phase 2b trial. The FDA refused to file this

2

NDA on the grounds that the NDA did not contain substantial evidence of effectiveness based on the single placebo-controlled Phase 2b clinical trial which had not achieve statistical significance in the pre-specified analysis. At the time, the FDA provided us feedback regarding conducting a subsequent Phase 3 clinical trial which became our ACT DMD trial.  In December 2015, we submitted a NDA to the FDA for approval of Translarna for the treatment of nmDMD, primarily based on our analysis of the results of our ACT DMD and Phase 2b trials. We anticipate that the FDA will notify us as to whether it has accepted our NDA filing in February 2016. If the NDA is accepted by the FDA, it is likely that the FDA will inform us of the date that their review of the NDA is expected to be completed.  We anticipate, based on timelines established by the Prescription Drug User Fee Act, or PDUFA, that, if accepted, the FDA review date will be in late summer of this year. If the FDA determines that there is not substantial evidence of effectiveness from our ACT DMD and Phase 2b trials and that the benefit-risk profile of Translarna is not favorable, the agency could refuse to approve Translarna, issue a Complete Response letter to the company, and request the completion of additional clinical trials.

In 2012, also primarily based on the results of our Phase 2b trial, we submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, seeking conditional approval of Translarna for the treatment of nmDMD. Conditional approval from the EMA is a mechanism to provide for a marketing authorization subject to non-renewal if certain obligations are not met, typically related to providing comprehensive clinical data from ongoing studies that confirm the risk-benefit balance of a drug therapy is positive.  In January 2014, EMA’s Committee for Medicinal Products for Human Use, or CHMP, adopted a negative opinion recommending the refusal of the granting of the conditional marketing authorization for Translarna. Following our request for re-examination of the CHMP opinion, we were notified in August 2014 that the European Commission had approved a conditional marketing authorization for Translarna for the treatment of nmDMD under a limited label for ambulatory nmDMD patients aged five years and older who have been identified through genetic testing.

The marketing authorization received by the European Commission in August 2014 was further conditioned on our submission of the final clinical study report, including additional efficacy and safety data, from our ongoing ACT DMD trial, and our ability to implement several post-approval measures, including pharmacovigilance plans, that are detailed in our risk management plan with the European Commission. In addition, this marketing authorization is subject to an annual review and renewal by the EMA following its reassessment of the risk-benefit balance of the authorization. In January 2016, we submitted the results from our ACT DMD clinical trial to the EMA. In connection with our submission of the ACT DMD report to the EMA, we requested that this specific condition to our marketing authorization be removed. If the EMA does not view the results of ACT DMD as favorable, if we fail to satisfy our obligations under the marketing authorization, or if it is determined that the balance of risks and benefits of using Translarna changes materially, the European Commission could, at the EMA’s recommendation, vary, suspend, withdraw or refuse to renew the marketing authorization for Translarna or require additional clinical trials. We currently anticipate the CHMP will make its recommendation to the EMA with respect to this request in mid-2016.

We believe that the collective data from our Phase 2b and ACT DMD trials, including pre-specified analyses as well as retrospective and subgroup analyses that we have performed,

3

provide support for concluding that Translarna was efficacious and showed clinically meaningful improvements over placebo in these trials.  However, we did not achieve the primary efficacy endpoint in either of our Phase 2b or ACT DMD trials with the pre-specified level of statistical significance and there is substantial risk that the FDA, the EMA and regulators in other territories will not agree with our interpretation of the results of ACT DMD and the totality of clinical data from our trials.  This may result in the company not achieving full regulatory approvals to market and sell Translarna in the commercial setting in any jurisdiction.  We expect to receive greater clarity on these regulatory outcomes within the next six months.

In the event that we are unable to obtain full regulatory approvals to market and sell Translarna in the commercial setting, we intend to direct substantially all work-in-process drug product to clinical supply.  The same Translarna drug product can be manufactured and utilized across our numerous ongoing clinical trials as well as for commercial use.

Since our receipt of the conditional marketing authorization in the EEA, we have assessed on a quarterly basis whether to capitalize the manufacturing costs related to our commercial supplies of Translarna under ASC 330-10 and Statement of Financial Accounting Concepts No. 6, paragraph 25. Given the substantial uncertainty and risk related to our ability to maintain our marketing authorization for Translarna and the ongoing uncertainty of realizing future economic benefit with respect to commercial sales of Translarna, we have continued to expense manufacturing costs as research and development expenses.

Given the number of steps in our manufacturing process, a full manufacturing cycle can take between 18 months and two years to manufacture our drug product from start to finish.  As Translarna can be utilized for either clinical or commercial, drug product is not directed to clinical or commercial use until the final finishing stage of the manufacturing process.  Since receiving the conditional marketing authorization, we have not completed a full manufacturing cycle for Translarna and the majority of all work-in-process manufactured product may still be potentially directed toward clinical or commercial use. Sales of Translarna during 2014 and 2015 were fulfilled with Translarna product that had completed the manufacturing process with their associated product manufacturing costs being previously expensed as research and development costs in fiscal periods prior to receipt of the conditional marketing authorization. At the time that such manufacturing costs were expensed, all drug product manufactured was intended for clinical use.

Today, all work-in-process manufacturing product may still be ultimately utilized for clinical use and given the uncertainties associated with obtaining full regulatory approvals, we have decided to continue to expense these costs, which we believe is in line with industry practice when there is significant uncertainty with obtaining full approval from regulators. We will continue to assess, on a quarterly basis, the timing of inventory capitalization based on any progress made with our regulatory processes over the coming months.  However, we acknowledge the third bullet point of the Staff’s comment and, commencing with our 2015 Form 10-K, we will record finishing costs associated with directing work-in-process drug product towards commercial drug packs as a sales, general and administrative expense.  If we are able to obtain full regulatory approvals from either the EMA or the FDA such that we are able to assert probable future economic benefit, we plan to begin capitalizing manufacturing and finishing costs for work-in-

4

process, commercially-directed drug product as inventory.  Concurrently, we will begin expensing these previously capitalized inventory costs as cost of goods sold as to better match expenses with revenues.

Rule 83 Confidential Treatment by PTC Therapeutics, Inc. Request #1

Total Translarna-related product manufacturing and finishing costs incurred in the first nine months of 2015 and for the year ended December 31, 2014, were approximately $[**] and $[**] million, respectively.  Of these amounts, approximately $[**] million and $[**] million was directly incurred for clinical supply finishing costs and approximately $[**] million and $[**] million was directly incurred for commercial supply finishing costs.  As noted above, we will classify these commercial finishing costs as sales, general and administrative expense, commencing with our 2015 Form 10-K. The remaining $[**] million and $[**] million, respectively, represent manufacturing costs for Translarna product that could be directed to either clinical or commercial use.  We estimate that approximately [**]% of this work-in-process manufacturing production could ultimately be directed for commercial use in the future, which would imply that product manufacturing costs incurred during the first nine months of 2015 and the year ended December 31, 2014 for commercial supply was approximately $[**] million and $[**] million, respectively.  Note however that should the company not receive full regulatory approvals from the FDA and EMA later this year, substantially all of this Translarna-manufactured product would be directed toward clinical supply, hence our rationale for recording these manufacturing costs as R&D expense given the uncertainty associated with obtaining regulatory approvals and the materiality of the amount relative to the company’s overall operating expenses.

PTC Therapeutics, Inc. respectfully requests that the information contained in Request #1 above be treated as confidential information and that the Securities and Exchange Commission provide timely notice to Shane Kovacs, Executive Vice President, Chief Financial Officer and Head of Corporate Development, PTC Therapeutics, Inc., 100 Corporate Court, South Plainfield, NJ, 07080, telephone 908-222-7000, before it permits any disclosure of the bracketed information contained in Request #1.

*    *    *

In connection with the Staff’s comment letter, the Company acknowledges that:

·                  the Company is responsible for the adequacy and accuracy of the disclosure in the filings;

·                  Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and

·                  the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

Should you have any further questions, please contact me at (908) 912-9466. Thank you for your time and attention to this matter.

Very   truly yours,

/s/   Shane Kovacs

Shane   Kovacs

Chief   Financial Officer

cc:           Office of Freedom of Information and Privacy Act Operations

Securities a

CORRESP
1
filename1.htm

January 21, 2016

FOIA CONFIDENTIAL TREATMENT REQUEST

The entity requesting confidential treatment is:

PTC Therapeutics, Inc.

100 Corporate Court

South Plainfield, NJ 07080

Attn: Shane Kovacs, Executive Vice President, Chief Financial Officer and

Head of Corporate Development

908-222-7000

BY EDGAR:

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Mail Stop 4720

Washington, D.C. 20549

Attention: Jim B. Rosenberg

Re:

PTC Therapeutics, Inc.

Form 10-K for the Fiscal Year Ended December 31,   2014

Filed March 2, 2015

Form 10-Q for the Quarterly Period Ended   September 30, 2015

Filed November 9, 2015

File No. 001-35969

Ladies and Gentlemen:

This letter is submitted on behalf of PTC Therapeutics, Inc. (the “Company”) in response to the comments in the letter dated December 15, 2015 (the “Comment Letter”) from Jim B. Rosenberg of the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) to Shane Kovacs, Chief Financial Officer of the Company, with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as filed with the Commission on March 2, 2015 (the “2014 Form 10-K”) and the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2015, as filed with the Commission on November 9, 2015 (the “2015 Third Quarter Form 10-Q”). The Staff’s comments are reproduced below in bold in the order in which they were set out in the Comment Letter and the Company’s corresponding responses are shown below the applicable comments and numbered accordingly.

Form 10-K for the Fiscal Year Ended December 31, 2014

Item 6.  Selected Financial Data, page 94

1.              You present only three years of statements of operations data in your table.  As information for 2011 was presented in your initial public offering registration statement on Form S-1, File Number 333-193677, please represent to us that you will include five years of information in your 2015 Form 10-K as required by Item 301(a) of Regulation S- K.  In addition, please represent that you will include the balance sheet information required by Instruction 2 to Item 301 of Regulation S-K in your 2015 Form 10-K.

Response to Comment No. 1

In response to the Staff’s comment, the Company confirms that in its Form 10-K for the fiscal year ended December 31, 2015, it will include (i) five years of information in the statement of operations table in Selected Financial Data as required by Item 301(a) of Regulation S- K and (ii) the balance sheet information required by Instruction 2 to Item 301 of Regulation S-K.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Critical accounting policies and significant judgments and estimates

Inventories and Cost of Product Revenues, page 100

2.              Please tell us why you have not capitalized any inventory costs for Translarna product manufactured for sale in Europe under your conditional approval and reference for us the authoritative literature you relied upon to support your accounting.  Please ensure your response also addresses the following:

·                       Tell us the amount of inventory costs you charged to expense in each fiscal year.

·                       Tell us the amount of inventory costs you charged to expense prior to receipt of conditional approval.

·                       Tell us why it is appropriate to charge inventory costs incurred after receipt of conditional approval to research and development expenses.  Explain to us how the ultimate commercial sale of this product meets the definition of research or development under ASC 730-10-20 by discovering new knowledge or translating that knowledge into new products, processes or techniques.

·                       Tell us the amount of royalties and other miscellaneous selling costs, as indicated on page 10 of your September 30, 2015 Form 10-Q, associated with your product sales that you have charged to research and development costs.  Explain to us how these costs meet the definition of research or development.

·                       Tell us the amount of zero-cost inventory you have on hand in terms of units, the number of units you have sold by reporting period through September 30, 2015 and why you do not provide any indication of the amount of this inventory on hand in your filings.

·                       Although you characterize the amount of cost of sales in 2014 as being insignificant, tell us what the cost of sales for 2014 and each quarter in 2015 would have been if you had not charged all your inventory costs to research and development expenses. Tell us your consideration for disclosing these amounts and why it is apparently not meaningful information for investors to understand the potential gross margins for Translarna.

Response to Comment No. 2

The Company believes it is important to understand its manufacturing process to help evaluate its responses to the Staff’s questions above.  It typically takes between 18 months and two years to manufacture the Company’s Translarna product from start to finish.   The manufacturing process includes a series of steps and various third party suppliers to convert the raw materials to the finished drug product.  Historically, 100% of finished Translarna drug product was produced for clinical study use and these manufacturing costs were therefore expensed as research and development expenses in accordance with Accounting Standards Codification (ASC) 730-10, Research and Development.

In August 2014, in connection with receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency (EMA) granted conditional marketing authorization for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in the European Economic Area (EEA), which we refer to herein as the conditional marketing authorization. A conditional marketing authorization granted by the EMA is only valid for a one-year period and must be renewed annually by the EMA following a regulatory re-assessment of the risk-benefit balance of the marketing authorization and the need for additional or modified conditions. Prior to receiving the conditional marketing authorization, the manufacturing cost for all Translarna product on hand had been expensed as research and development costs in prior fiscal periods.

Rule 83 Confidential Treatment by PTC Therapeutics, Inc. Request #1

Sales of commercial product during 2014 and 2015 were fulfilled with Translarna product that had completed the manufacturing process and the associated product manufacturing costs had been expensed as research and development costs in fiscal periods prior to receipt of the conditional marketing authorization. Following the receipt of the conditional marketing authorization, the Company incurred finishing costs that include packaging costs and indirect overhead costs that were specific to directing this previously expensed clinical product for use as commercial supply during 2014 and 2015.  For the nine months ended September 30, 2015 and for the year ended December 31, 2014, the Company expensed approximately $[**] and $[**], respectively, of aggregate Translarna product manufacturing and finishing costs which included both clinical research directed product and commercial supply.  Approximately $[**] and $[**] represent finishing costs that were incurred to direct product to commercial use for the nine months ended September 30, 2015 and for the year ended December 31, 2014, respectively. The Company determined that it was appropriate to classify these product manufacturing and finishing costs as research and development expense rather than capitalizing these costs as inventory given a) the ongoing uncertainty associated with the conditional marketing authorization from the EMA and b) the fact that these product manufacturing and finishing costs were immaterial to its financial statements given that these costs amounted to less than [**]% of the Company’s total aggregate operating expense for the same periods.

Prior to the receipt of conditional marketing authorization, a total of approximately $[**] of Translarna product manufacturing costs, which has since been directed for commercial supply, had been expensed as research and development costs.

PTC Therapeutics, Inc. respectfully requests that the information contained in Request #1 above be treated as confidential information and that the Securities and Exchange Commission provide timely notice to Shane Kovacs, Executive Vice President, Chief Financial Officer and Head of Corporate Development, PTC Therapeutics, Inc., 100 Corporate Court, South Plainfield, NJ, 07080, telephone 908-222-7000, before it permits any disclosure of the bracketed information contained in Request #1.

The Company has not completed a full manufacturing cycle for its product since it received conditional marketing authorization and has continued to expense early stage product manufacturing costs given the substantial uncertainty and risk related to the Company’s ability to maintain its authorization to market Translarna which could therefore render all future product manufacturing for clinical research use.

Since the time of receiving the conditional marketing authorization, there has been, and continues to be, substantial uncertainty and risk related to the Company’s ability to maintain its authorization to market Translarna for the treatment of nmDMD in the EEA. It is important to note that a conditional marketing authorization is subject to annual review and renewal by the EMA following its reassessment of the risk-benefit balance of the marketing authorization. The Company’s conditional marketing authorization was further conditioned on its submission of the final report, including additional efficacy and safety data, from the Company’s Phase 3 clinical trial of Translarna in patients with nmDMD (ACT DMD), which report was submitted to the EMA in January 2016. The Company’s submission of this report is subject to review and consideration by the European Commission, EMA and CHMP.

In October 2015, the Company announced results from ACT DMD, including that the trial did not meet the primary efficacy endpoint in the 6-minute walk test with the pre-specified level of statistical significance.  While the Company believes that the totality of clinical data from ACT DMD and its prior Phase 2b trial support the clinical benefit of Translarna for the treatment of nmDMD, there is substantial risk that the EMA and regulators in other geographic territories will not agree with the Company’s interpretation of the results of ACT DMD and the totality of clinical data from its trials.

If the Company fails to satisfy the applicable renewal requirements for its conditional marketing authorization, or if the EMA determines that the balance of risks and benefits of using Translarna for nmDMD changes materially, the European Commission could, at the EMA’s recommendation, vary, suspend, withdraw or refuse to renew the conditional marketing authorization for Translarna or require additional clinical trials.

In addition, other than with respect to the conditional marketing authorization, the Company does not have historical experience with, and has not proven its ability to successfully develop product candidates or obtain regulatory approvals to sell Translarna or its other product candidates and there currently are no other drugs approved for nmDMD and the regulatory process is still unknown.

Given the substantial risk with respect to the Company’s ability to continue to generate future revenue from sales of Translarna under the conditional marketing authorization or otherwise, the Company concluded that it would be inappropriate to capitalize inventory for the year ended December 31, 2014 and the nine months ended September 30, 2015. The Company will continue to assess the appropriateness of inventory capitalization based on the outcome of applicable regulatory approvals.

Rule 83 Confidential Treatment by PTC Therapeutics, Inc. Request #2

With respect to royalties and other miscellaneous selling costs, and in the same context as determined with respect to product manufacturing and finishing costs, the Company determined that these costs were immaterial to its financial statements and classified them as research and development expense.  This again was a result of both the ongoing uncertainty associated with the conditional marketing authorization from the EMA and the fact that these commercial supply-related costs were immaterial to its financial statements.   For the nine months ended September 30, 2015 and for the year ended December 31, 2014, royalties expensed totaled $[**] and [**]$[**], respectively.  For the same periods, miscellaneous selling costs, which consist of distribution costs, totaled $[**] and [**]$[**], respectively. Although such costs do not meet the definition of research or development under ASC 730-10-20, the royalties and other miscellaneous selling costs amount to less than [**]% of the Company’s overall operating expense for the same periods and the inclusion of these costs in research and development expense do not materially impact the Company’s financial statements or the trends therein with respect to the Company’s increasing research and development expense over the affected reporting periods.   Commencing with our 2015 Form 10-K, the Company will classify miscellaneous selling costs in selling, general and administrative expense.

As of September 30, 2015, approximately [**] zero cost units of finished Translarna product labeled for commercial sale were on hand.  Commencing with the 2015 Form 10-K, the Company intends to disclose additional information concerning its use of zero-cost inventory as presented below under the heading “Inventories and Cost of Product Revenues.”

PTC Therapeutics, Inc. respectfully requests that the information contained in Request #2 above be treated as confidential information and that the Securities and Exchange Commission provide timely notice to Shane Kovacs, Executive Vice President, Chief Financial Officer and Head of Corporate Development, PTC Therapeutics, Inc., 100 Corporate Court, South Plainfield, NJ, 07080, telephone 908-222-7000, before it permits any disclosure of the bracketed information contained in Request #2.

The following Table 1 reports the number of zero cost units sold in the fiscal year ended December 31, 2014 and each of the fiscal quarters ended March 31, June 30, and September 30, 2015 as well as the associated product manufacturing and finishing costs described above that were either incurred and expensed prior to receiving conditional marketing authorization or incurred following the Company’s receipt of conditional marketing authorization for product that was directed for commercial sale.

Rule 83 Confidential Treatment by PTC Therapeutics, Inc. Request #3

Table 1.

Implied Cost of Translarna Product Sold and Expensed as R&D vs. COGS

($ in thousands)

2014

Q1
   2015

Q2
   2015

Q3
   2015

Units Sold

[**]

[**]

[**]

[**]

Cost of   Translarna product-including manufacturing & finishing costs

$

[**]

$

[**]

$

[**]

$

[**]

Royalties on   Translarna sales

$

[**]

$

[**]

$

[**]

$

[**]

Total   implied cost of Translarna product sales expensed as R&D vs. COGS

$

[**]

$

[**]

$

[**]

$

[**]

The following Table 2 reports the implied cost of goods sold (COGS), implied gross profit and implied gross margin for fiscal year 2014 and each quarter in 2015 through September 30, 2015. As indicated in Table 2, had the Company capitalized all product manufacturing and finishing costs for Translarna product that was subsequently directed for commercial use at the time it was manufactured, the Company’s gross prof

CORRESP
1
filename1.htm

January 13, 2016

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Mail Stop 4720

Washington, D.C. 20549

Attention: Jim B. Rosenberg

Re:

PTC   Therapeutics, Inc.

Form 10-K   for the Fiscal Year Ended December 31, 2014

Filed   March 2, 2015

Form 10-Q   for the Quarterly Period Ended September 30, 2015

Filed   November 9, 2015

File   No. 001-35969

Ladies and Gentlemen:

PTC Therapeutics, Inc. (the “Company”) confirms that it is in receipt of a comment letter (the “Comment Letter”) from the Staff (the “Staff”) of the Securities and Exchange Commission, dated December 15, 2015, regarding the above-referenced filings of the Company. The Company is working diligently to complete its response to the Staff, but due to logistical issues, including the end of the holiday season and management team travel schedules, requires additional time to finalize its response. On January 13, 2016, a representative of the Company spoke with the Staff and the Staff agreed to provide an additional one week extension for the Company’s response. The Company appreciates the Staff’s willingness to allow for the additional time and the Company will provide its response on or before January 21, 2016.

Please call the undersigned at (908) 912-9466 if you have any questions regarding this letter.

Very truly yours,

/s/ Shane Kovacs

Shane Kovacs

Chief Financial Officer

CORRESP
1
filename1.htm

December 16, 2015

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Mail Stop 4720

Washington, D.C. 20549

Attention: Jim B. Rosenberg

Re:                 PTC Therapeutics, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2014

Filed March 2, 2015

Form 10-Q for the Quarterly Period Ended September 30, 2015

Filed November 9, 2015

File No. 001-35969

Ladies and Gentlemen:

PTC Therapeutics, Inc. (the “Company”) confirms that it is in receipt of a comment letter (the “Comment Letter”) from the Staff (the “Staff”) of the Securities and Exchange Commission, dated December 15, 2015, regarding the above-referenced filings of the Company. The Comment Letter requests that the Company respond within 10 business days or tell the Staff when the Company will respond. On December 16, 2015, a representative of the Company spoke with the Staff and the Staff agreed to provide a 10 business day extension for the Company’s response. The Company appreciates the Staff’s willingness to allow for the additional time and the Company will provide its response on or before January 14, 2016.

Please call the undersigned at (908) 912-9466 if you have any questions regarding this letter.

Very truly yours,

/s/ Shane Kovacs

Shane Kovacs

Chief Financial Officer

Mail Stop 4720

December  15, 2015

Via E -mail
Mr. Shane Kovacs
Chief Financial  Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, New Jersey 07080

Re: PTC Therapeutics, Inc.
 Form 10-K for the Fiscal Year Ended December  31, 201 4
Filed March 2 , 2015
Form 10 -Q for the Quarterly Period Ended September 30, 2015
Filed November 9, 2015
 File No. 001-35969

Dear Mr. Kovacs :

We have limited our review of your filings to the financial statements and related
disclosures  and have the following comments .  In our comment s, we ask you to provide us with
information so we may better understand your disclosure.

Please respond to th ese comment s within 10 busine ss days by providing the requested
information or advis e us as soon as possible  when you will respond .  If you do not believe  that a
comment applies to your facts and circumstances, please tell us why in your response.

After reviewing your response to t hese comments , we may have additional comments.

Form 10 -K for the Fiscal Year Ended December 31, 201 4

Item 6.  Selected Financial Data, page 94

1. You present only three years of statements of operations data in your table.  As
information for 2011 was presented in your initial public offering registration statement
on Form S -1, File Number 333 -193677, please represent to us that you will include fiv e
years of information in your 2015 Form 10 -K as required by Item 301(a) of Regulation S -
K.  In addition, please represent that you will include the balance sheet information
required by Instruction 2 to Item 301 of Regulation S -K in your 2015 Form 10 -K.

Mr. Shane Kovacs
PTC Therapeutics, Inc.
Dece mber 15, 201 5
Page 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical accounting policies and significant judgments and estimates
Inventories and Cost of Product Revenues, page 100

2. Please tell us why you have not capitalized a ny inventory costs for Translarna product
manufactured for sale in Europe under your conditional approval and reference for us the
authoritative literature you relied upon to support your accounting.  Please ensure your
response also addresses the followin g:
 Tell us the amount of inventory costs you charged to expense in each fiscal year.
 Tell us the amount of inventory costs you charged to expense prior to receipt of
conditional approval.
 Tell us why it is appropriate to charge inventory costs incurred aft er receipt of
conditional approval to research and development expenses.  Explain to us how the
ultimate commercial sale of this product meets the definition of research or
development under ASC 730 -10-20 by discovering new knowledge or translating that
knowledge into new products, processes or techniques.
 Tell us the amount of royalties and other miscellaneous selling costs, as indicated on
page 10 of your September 30, 2015 Form 10 -Q, associated with your product sales
that you have charged to research and development costs.  Explain to us how these
costs meet the definition of research or development .
 Tell us the amount of zero -cost inventory you have on hand in terms of units, the
number of units you have sold by reporting period through September 30, 2015 and
why you do not provide any indication of the amount of this inventory on hand in
your filings.
 Although you characterize the amount of cost of sales in 2014 as being insignificant,
tell us what the cost of sales for 2014 and each quarter in 2015 would have been if
you had not charged all your inventory costs to research and development expenses.
Tell us your consideration for disclosing these amounts and why it is apparently not
meaningful information for investors to understand the potential gro ss margins for
Translarna.

Form 10 -Q for the Quarterly Period Ended September 30, 2015

Notes to Consolidated Financial Statements
Note 2:  Summary of significant accounting policies
Revenue Recognition
Net Product Sales, page 11

3. Please tell us whether you grant the right of return to your Translarna customers.  If so,
please tell us the provisions of your return policy and demonstrate to us how you were
able to make reasonable estimates of returns as required by ASC 605 -15-25-1f in order to
record revenue upon product shipment effective January 1, 2015.  In this regard, you
disclose on page 4 of your 2014 Form 10 -K that Translarna is the first ever approved

Mr. Shane Kovacs
PTC Therapeutics, Inc.
Dece mber 15, 201 5
Page 3

 treatment for the underlying cause of nonsense mutation Duchenne muscular d ystrophy
and that you did not launch Translarna on a commercial basis until December 2014.

 We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing s to be certain that the filing s include all information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require.  Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures th ey have made.

 In responding t o our commen ts, please provide  a written statement from the company
acknowledging that:

 the company is responsible for the adequacy and accuracy of the disclosure in the filing s;
 staff comment s or changes to disclosu re in response to staff comment s do not foreclose
the Commission from taking any action with respect to the filing s; and
 the compa ny may not assert the staff comment s as a defense in any proceeding initiated
by the Commission or any person under the federal secu rities laws of the United States.

You may contact Mark Bru nhofer, Senior Staff Accountant, at (202) 551 -3638 or Sharon
Blume, Accounting Branch Chief, at (202) 551 -3474 if you have questions regarding the
comment s.  In this regard, do not hesitate to contact me at (202) 551 -3679 .

Sincerely,

/s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief Accountant
Office of Healthcare and Insurance

CORRESP
1
filename1.htm

J.P. MORGAN SECURITIES LLC
    383 Madison Avenue
   New York, NY 10179

CREDIT SUISSE SECURITIES (USA) LLC

Eleven Madison Avenue
   New York, NY 10010

June 17, 2013

Re:                        PTC Therapeutics, Inc.
 Registration Statement on Form S-1
 Registration File No. 333-188657

Securities and Exchange Commission
 Division of Corporation Finance
 100 F Street, N.E.
 Washington, D.C. 20549

Dear Sir/Madam:

Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933 (the “Act”), we, as representatives of the several Underwriters, wish to advise you that 3,008 copies of the Preliminary Prospectus included in the Registration Statement on Form S-1 were distributed during the period June 5, 2013 through 5:00 p.m. Eastern time, June 14, 2013, to prospective underwriters, institutions, dealers and others.

We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934.

In accordance with Rule 461 of the Act, we hereby join in the request of PTC Therapeutics, Inc. for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:00 p.m. Eastern time on June 19, 2013, or as soon thereafter as practicable.

[Remainder of page intentionally left blank]

Very truly yours,

By:

J.P. MORGAN SECURITIES LLC

By:

/s/ Sri Kosaraju

Name:

Sri Kosaraju

Title:

Managing Director

By:

CREDIT SUISSE SECURITIES (USA) LLC

By:

/s/ Jill Ford

Name:

Jill Ford

Title:

Managing Director

CORRESP
1
filename1.htm

PTC THERAPEUTICS, INC.
 100 CORPORATE COURT
 SOUTH PLAINFIELD, NEW JERSEY 07080

June 17, 2013

Via EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Re:              PTC Therapeutics, Inc.
 Registration Statement on Form S-1
 File No. 333-188657
 Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, PTC Therapeutics, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-188657), as amended (the “Registration Statement”), so that it may become effective at 4:00 p.m. Eastern time on June 19, 2013, or as soon thereafter as practicable.

The Registrant hereby acknowledges that:

(a)                                 should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement;

(b)                                 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and

(c)                                  the Registrant may not assert staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

[The remainder of this page is intentionally left blank.]

Very truly yours,

PTC Therapeutics, Inc.

By:

/s/ Mark E. Boulding

Name:

Mark E. Boulding

Title:

Executive Vice President and

Chief Legal Officer

June 12 , 2013

Via E -mail
Stuart M. Peltz, Ph.D.
Chief Executive Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ  07080

Re: PTC Therapeutics, Inc.
Amendment No. 2 to Registration Statement on Form S -1
Filed June 5,  2013
  File No. 333 -188657

Dear Dr. Peltz:

We have reviewed your amended registration statement filed June 5, 2013 and have  the
following comment .

Please respond to this letter by amending your registration statement or providing the
requested information.   If you do not believe our comment  applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in yo ur
response.

After reviewing any amendment to your registration statement and the information you
provide in response to our comment, we may have additional comments.

Business, page 76
Ataluren, page 80

1. We note your disclosure on page 80 and page 35 that the FDA has granted fast track
designation to ataluren for the treatment of nmDMD and nmCF.  Your disclosure on page
133, however, refers only to fast track designation from the FDA for the treatment of
nmDMD.  Please advise us as to the s tatus of your discussions with the FDA regarding a
potential fast track designation for ataluren for the treatment of nmCF and explain the
inconsistencies in your disclosure.  If you have not obtained fast track designation for the
treatment of nmCF, pleas e revise your disclosure to accurately reflect the fast track status
of ataluren.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities  Act of 1933 and
all applicable Securities Act rules require.   Since the company and its management are in

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
June 12 , 2013
Page 2

 possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

You may contact Ibolya Ignat, Staff Accountant, at (202) 551 -3656 or Gus Rodriguez,
Accounting Branch Chief, at (202) 551 -3752 if you have questions regarding comments on the
financial statements and related matters.  Please contact Karen Ubell, Staff Atto rney, at (202)
551-3873, Dan Greenspan, Legal Branch Chief, at (202) 551 -3623 or me at (202) 551 -3715 with
any other questions.

Sincerely,

 /s/ Daniel Greenspan for

Jeffrey P. Riedler
Assistant Director

cc: Via E -mail
 Clark W. Petschek
Wilmer Cutler Pickering Hale and Dorr  LLP

May 23, 2013

Via E -mail
Stuart M. Peltz, Ph.D.
Chief Executive Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ  07080

Re: PTC Therapeutics, Inc.
Registration Statement on Form S -1
Filed May 16, 2013
  File No. 333 -188657

Dear Dr. Peltz:

We have reviewed your registration statement and letter submitted May 16, 2013, and
have  the following comments.  In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.

Please respond to this letter by amending your registration statement and providing the
requested information.   If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in r esponse to these comments, we may have additional comments.

Unaudited Financial Statements March 31, 2013
Notes to Unaudited Financial Statements

2. Summary of Significant Accounting Policies
Basis of Presentation, page F -33

1. Please tell us the reason  for including the statement “The December 31, 2012  balance
sheet was derived from audited financial statements, but does not include  all disclosures
required by U.S. generally accepted accounting principles” in your  disclosure.

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
May 23, 2013
Page 2

 5. Capital Structure, page F -37

2. Please describe how you allocated the proceeds of the convertible promissory  notes
between the debt and the warrant liability. Reference for us the  authoritative literature
you relied upon to support your accounting. Quantify and  discuss any significant
assumptions underlying your allocation.

3. You disclose that since the value of the warrants exceeded the proceeds from the
convertible notes it was considered a deemed dividend and was reflected as an  equity
transaction in your financial stateme nts. Please reference for us the  authoritative literature
you relied upon to support your presentation of the deemed  dividend in your statements
of operations.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commissi on from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and acc uracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for acceleration.  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their  respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time for us to revi ew any amendment prior to the requested effective date of the
registration statement.

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
May 23, 2013
Page 3

 You may contact Ibolya Ignat, Staff Accountant, at (202) 551 -3656 or Gus Rodriguez,
Accounting Branch Chief, at (202) 551 -3752 if you have questions regarding comme nts on the
financial statements and related matters.  Please contact Karen Ubell, Staff Attorney, at (202)
551-3873, Dan Greenspan, Legal Branch Chief, at (202) 551 -3623 or me at (202) 551 -3715 with
any other questions.

Sincerely,

 /s/ Daniel  Greenspan  for

Jeffrey P. Riedler
Assistant Director

cc: Via E -mail
 Clark W. Petschek
Wilmer Cutler Pickering Hale and Dorr LLP

May 7, 2013

Via E -mail
Stuart M. Peltz, Ph.D.
Chief Executive Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ  07080

Re: PTC Therapeutics, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S -1
Submitted April 23 , 2013
  CIK No. 0001070081

Dear Dr. Peltz :

We have reviewed your amended draft registration statement  and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.

Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumst ances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to these  comments  and your
amended draft registration statement or filed registration statement,  we may have additional
comments.

Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Share -based Compensation, page 61

1. We acknowledge your response to comments 10, 11 and 30 and your revised disclosures.
In order for us to fully understand the equity fair market valuations reflected in your
financial statements please provide an itemized chronological schedule in a tabular
format covering all equity instruments issued in the periods presented through the date of
your response to complement your existing tabular disclosure on page 63 and the related
narrative disclosures.  Your current disclosure only addresses your stock options grant
issuances.  For each equity instrument issuance, please include the information requested
by prior comment 10.  In your response to comment 11 you make reference to a tabular
disclosure that does not appear to be included in your current amendment.  Please include

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
May 7 , 2013
Page 2

 the tabular disclos ure and provide the information requested in prior comment 11 when
your IPO price is established.

General

If you intend to respond to these comments with an amended draft registration statement ,
please submit it and any associated correspondence in ac cordance with the guidance we provide
in the Division’s October 11, 2012 announcement on the SEC website at
http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm .

You may contact  Ibolya Ignat, Staff Accountant , at (202) 551 -3656 or Gus Rodriguez,
Accounting Branch Chief, at (202) 551 -3752  if you have questions regarding comments on the
financial statements and related matters.  Please contact Karen Ubell, Staff Attorney , at (202)
551-3873, Dan Greenspan, Legal Branch Chief, at (202) 551 -3623  or me at (202) 551 -3715  with
any other questions.

Sincerely,

 /s/ Daniel Greenspan for

Jeffrey P. Riedler
Assistant Director

cc: Via E -mail
 Clark W. Petschek
Wilmer Cutler Pickering Hale and Dorr LLP

April 15, 2013

Via E -mail
Stuart M. Peltz, Ph.D.
Chief Executive Officer
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, NJ  07080

Re: PTC Therapeutics, Inc.
Draft Registration Statement on Form S -1
Submitted March 18, 2013
  CIK No. 0001070081

Dear Dr. Peltz :

We have reviewed your draft registration statement  and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.

Please respond to this le tter by providing the requested information and either submitting
an amended draft registration statement or  publicly  filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in re sponse to these  comments  and your
amended draft registration statement or filed registration statement,  we may have  additional
comments.

General

1. Please submit all exhibits as soon as practicable.  We may have further comments upon
examination of these exhibits.

2. Please provide us proofs of all graphic, visual or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.

3. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, that you , or anyone authorized to do so on your
behalf , present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.   Similarly, please
supplementally provide us with any research reports about you that are published or

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
April 1 5, 2013
Page 2

 distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by
Section  105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is
participating or will participate in your offering.

4. Comments to your application for confidential treatment will be delivered under separate
cover.

Prospectus Summary, pa ge 1
Risks associated with our business, page 5

5. Please expand the second bullet point in this section to note that certain of your prior
clinical trials were not successful in achieving specified primary endpoints.

Our corporation information, page 5

6. Please note that it is not appropriate to state or imply that you do not have liability for the
statements in your registration statement. The statement “we have not independently
verified” data obtained from third -party sources appears to imply that you a re not taking
liability for the statistical and other industry and market data included in your registration
statement. In order to eliminate any inference that you are not liable for all of the
information in your registration statement, please delete thi s statement or include a
statement specifically accepting liability for these statements.

Risk Factors, page 11

7. Please include a risk factor discussing the risks associated with conducting a retrospective
analysis after unblinding test results and explain why r egulatory authorities typically give
greatest weight to results from pre -specified analyses and adjusted p -values and less
weight to results from post -hoc, retrospective analyses and  nominal p -values.

“If clinical trials of our product candidates…,” page 14

8. This extensive and lengthy risk factor highlights many material risks with more specific
discussion than the heading may indicate.  Please divide this risk factor into separate risk
factors or provide subheadings highlighting more sp ecifically each of the risks addressed.
For example, you should include a separately headed risk factor or subheading discussing
the possibility that the EMA will not grant conditional approval of ataluren for the
treatment of DMD and that you may experie nce unforeseen events that could delay or
prevent your ability to receive marketing approval or commercialize your product
candidates.

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
April 1 5, 2013
Page 3

 Management’s discussion and analysis of financial condition and results of operations, page 55
Critical accounting p olicies and significant judgments and estimates, page 59

9. Please disclose your election with respect to Section 107(b) of the JOBS Act and include
a statement highlighting the risk that your financial statements may not be comparable to
companies that com ply with public company effective dates .

Share -based Compensation, page 60

10. Please provide the following information separate ly for each equity instrument  issuance
through the date of your response:
 The date of the transaction,
 The number of equity ins truments granted or shares issued,
 The exercise price of equity instruments granted if any,
 Management’s estimated fair market value per share and how the estimate was
developed.  Please disclose the judgments made regarding future trends and factors
and i ndicate w hether or not the valuation was contemporaneous or re trospective ,
 The identity of the recipient, indicating if the recipient was a related party,
 The nature and terms of concurrent transactions; and,
 The amount of any compensation or interest expe nse element.

11. After your IPO price range has been set, disclose  each significant factor contributing to
the difference between the fair value as of the date of each grant  of equity instrument
issued, including options, any warrants classified as equity instruments, and preferred
stock  and the estimated IPO price or when a contemporaneous valuation by an unrelated
valuation specialist was obtained subsequent to the grants b ut prior to the IPO, the fair
value as determined by that valuatio n.  Reconcile and explain the differences between the
mid-point of your estimated offering price range and the fair values included in your
analysis.  Please ensure that all of your equity i nstruments issued during the periods
presented are included in your tabular disclosure.  Revise your tabular disclosure as
necessary to include information for all equity instruments issued subsequent to the
balance sheet date through the date of your late st response.

Liquidity and Capital Resources, page 65

12. Please include a summary of all of the equity financing activities completed in the
periods presented and through the date of your response.  Please also clarify and discuss
the “additional financing event” that is referred to in your Subsequent events not e on
page F -25.

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
April 1 5, 2013
Page 4

 Business, page 69
Our product development programs, page 72

13. Please expand your disclosure to indicate whether you have an IND for ataluren in each
indication.  Please also add disclosure regarding orphan designations.

Planned  Phase 3 clinical trial of ataluren for nmDMD, page 76

14. Please describe how you intend to attract or recruit patients for your trials.

Regulatory status and strategy for nmDMD, page 79

15. Please expand your disclosure to discuss the extent to which you and potential investors
may rely on the statement that “the FDA indicated that … the study design for the
proposed clinical trial, in general, was appropriate for providing evidence of efficacy of
ataluren.”

Post-hoc analysis of Phase 2b clinical trial data, page 84

16. Please explain on page 86 why r egulatory authorities typically give greatest weight to
results from pre -specified analyses and adjusted p -values and less weight to results from
post-hoc, retrospective analyses and  nominal p -values.

Safety  and tolerability, page 91

17. Please specifically describe the adverse events observed during the trial, with particular
focus on the serious adverse events.  In addition, please explain how you determined that
these serious adverse events were not ataluren -related.

Completed Phase 3 clinical trial of ataluren for nmCF, page 96

18. Please disclose why 34 patients withdrew prematurely from the trial.

19. You disclose on page 96 that the EMA has advised you of certain matters that may need
to be further a ddressed in your MAA. Please briefly elaborate on the items provided in
the bulleted list on page 96 to give added context to each of the matters to clarify the
nature of the FDA’s concerns and how you plan to address these in your MAA.

Safety and toler ability, page 99

20. Please specifically describe the adverse events observed during the trial, with particular
focus on the serious adverse events.  In addition, please explain how you determined that
the most serious adverse events were “unrelated to study drug treatment.”

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
April 1 5, 2013
Page 5

 Open label extension trial of ataluren for treatment of nmCF, page 100

21. Your disclosure indicates that you have not observed increases in frequency of previously
reported adverse events or significant numbers of new adverse events in the  open label
extension trial.  Please expand your discussion to disclose the adverse events you have
observed noting the new adverse events particularly.

Intellectual Property, page 113

22. Your disclosure in the third paragraph of this section discusses the patent rights relating
to ataluren owned by you.  Please add similar disclosure regarding any material patent
rights relating to ataluren that you license.

Competition , page 115

23. Please explain why you do not believe Kalydeco or the two other product candidates that
Vertex is developing for the treatment of cystic fibrosis are applicable for the treatment of
patients with nmCF.

Director compensation, page 142

24. We note your disclosure on page 143 that you intend to approve a compensation policy
for n on-employee directors that will become effective upon closing of the offering.  Once
approved, please update your disclosure to describe the adopted compensation plan.

Lock -up agreements, page 159

25. Once available, please file copies of each of the lock -up agreements.

Financial Statements
Statements of Operations, page F -4

26. Please tell us why you excluded the gain on exchange of convertible preferred stock in
connection with your recapitalization and the beneficial conversion charge from your Net
Loss for  2012.

Notes to Financial Statements
Revenue Recognition, page F -10

27. Please tell us how the accounting policy that you recognize grant and collaboration
revenue when invoiced is appropriate.  Please also clarify whether there are any refund  or
repayment obligations associated with your grants.  If so, please disclose the nature of
these obligations and tell us how the recognition of revenue is appropriate.   Please also
tell us why you have classified the grant received as revenue as opposed to o ther income.

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
April 1 5, 2013
Page 6

Beneficial conversion, page F -11

28. You disclose that the beneficial conversion feature results from the excess of the
proceeds allocated to the Series Three convertible preferred stock.  Please provide us with
the computation of the benefici al conversion charge in 2012.

Fair value of financial instruments and investments, page F -13

29. Please disclose th e assumptions used to determine the fair value of the warrant liability in
2012 and 2011.

Recapitalization, page F -17

30. Please disclose how y ou determined the value of the Series One, Series Two and Series
Three preferred stock issued in connection with the July 2012 recapitalization.  Please be
sure to describe the model used to estimate the fair values and all of the relevant
assumptions.  Pl ease also provide us with the computations of how you determined the
fair value of the Series One, Series two and Series Three preferred stock.

31. Please tell us the business purpose of the recapitalization transaction completed in July
2012 from the perspec tive of the Series A though G holders of convertible preferred stock
and the Series One, Series Two and Series Three convertible preferred stockholders and
why the recapitalization made economic sense for each series of preferred stockholders.
Please also  tell us why only the Series One preferred stockholders contributed proceeds
of $29.7 million in the recapitalization transaction and why the Series A through G
holders of preferred stock exchanged all of their interest for Series Two and Series Three
preferred stock.

32. Please provide us with an analysis that supports your accounting for the gain of $160
million in 2012 on the exchange of convertible preferred stock.

10.  Collaborations and Grants
Terminated Collaborations
Genzyme, page F -21

33. Please di sclose the amount of the additional payment received in exchange for an option
to commercialize ataluren in indications other than nonsense mutation Duchenne
muscular dystrophy outside the United States and Canada.  Please also disclose how you
accounted f or deferred revenue when you received notification that Genzyme terminated
the collaboration agreement.

34. You disclose that you recorded a one -time adjustment to your deferred revenue balance
upon the restructuring of your agreement with Genzyme in August 2011 “ to reflect the

Stuart W. Peltz, Ph.D.
PTC Therapeutics, Inc.
April 1 5, 2013
Page 7

 value of the remaining performance obligations under the restructured agreement as
represented by the best estimate of selling price .”  Please tell us how y ou calculated the
adjustment to your deferred revenue in connection with this r estructuring and all of the
relevant assumptions.

35. While you disclose on page F -10 that you use the “updated multiple element revenue
recognition guidance” for material modifications to your collaborations, it is unclear how
you determined that there was  a material modification.  Please revise your disclosures to
clarify how you determined that the modifications were material.

Roche and SMA Foundation, page F -22

36. Please disclose the estimated performance period and the factors considered in
determining  what appears to be a relatively short performance period.

14.  Subsequent events, page F -25

37. You disclose that in March 7, 2013 you issued and sold 4,497,035 shares of series four
senior preferred stock and an aggregate of 502,919 shares of your series f our senior
preferred stock upon conversion of the convertible promissory notes issued in January
and February 2013.  Please disclose how you plan to account for the January and
February 2013 convertible promissory note issuances, for the conversion of the
convertible promissory notes, for the issuance of warrants at an exercise price of $.01 and
for the exchange of the outstanding preferred stock that resulted in  another
recapitalization event.

38. Please disclose how you determined the value of the Series O ne, Series Two and Series
Three preferred stock issued in connection with the March 7, 2013 recapitalization.
Please be sure to describe the model used to estimate the fair values and all of the
relevant assumptions.  Please also provide us with the compu tations of how you
determined the fair value of the Series One, Series two and Series Three preferred stock.

General

If you intend to respond to these comments with an amended draft registration statement ,
please submit it and any associated correspondence in accordance with the guidance we provide
in the Division’s October 11 , 2012 announcement on the SEC website at
http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm .

Please keep in mind that we may publicly post filing review correspondence in
accordance with our December 1, 2011 policy
(http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ).  If you
intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of