UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On March 28, 2025, PTC Therapeutics, Inc. issued a press release announcing that the European Commission has decided to adopt the negative opinion issued by the Committee for Medicinal Products for Human Use (the “CHMP”) of the European Medicines Agency for the renewal of the conditional marketing authorization for TranslarnaTM (ataluren). The press release is furnished as Exhibit 99.1 to this Report. The European Commission’s Implementing Decision is furnished as Exhibit 99.2 to this Report.
The information in this Report (including Item 7.01 and Exhibits 99.1 and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. All website addresses given in this Report or incorporated herein by reference are for information only and are not intended to be an active link or to incorporate any website information into this Report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated March 28, 2025 issued by PTC Therapeutics, Inc. | |
| 99.2 | European Commission Implementing Decision of March 28, 2025 | |
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
| PTC Therapeutics, Inc. | ||
| Date: March 28, 2025 | By: | /s/ Pierre Gravier |
| Name: | Pierre Gravier | |
| Title: | Chief Financial Officer | |