UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On September 15, 2023, PTC Therapeutics, Inc. (the “Company”) issued a press release announcing that the Committee for Medicinal Products for Human Use of the European Medicines Agency (“CHMP”) delivered an opinion on TranslarnaTM (ataluren) for conversion to full authorization, furnished as Exhibit 99.1 to this Report.
The Company will host a conference call on September 15, 2023 at 8:45 AM Eastern time. Directions on how to access the conference call are included in the press releases attached to this Report.
The information in this Item 7.01 of this Report, including Exhibit 99.1 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 8.01. Other Events.
On September 15, 2023, the Company announced that the CHMP has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy. The negative opinion also applies to the renewal of the existing conditional authorization. PTC plans to submit a request for re-examination per European Medicines Agency guidelines.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
| Description |
99.1 | Press Release, dated September 15, 2023 issued by PTC Therapeutics, Inc. | |
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: September 15, 2023 | By: | /s/ Mark E. Boulding |
Name: | Mark E. Boulding | |
Title: | Executive Vice President and Chief Legal Officer | |