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 21, 2026, PTC Therapeutics, Inc. (the “Company”) issued a press release announcing that it completed the previously announced agreement with Sangamo Therapeutics, Inc. (“Sangamo”) to acquire ST-920, a BLA-stage one-time administered AAV gene therapy product candidate for Fabry disease, (the “Acquisition”). The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is incorporated by reference into this Item 7.01.
The information in this Item 7.01, 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 Information.
On September 21, 2026, the Company issued a press release announcing it completed the Acquisition. As previously disclosed, a rolling biologics license application (“BLA”) submission to the U.S. Food and Drug Administration for accelerated approval of ST-920 is expected to be completed in the fourth quarter of 2026. The BLA is based on the evidence of meaningful favorable clinical effect on renal function and safety and tolerability profile over 52 weeks in the Phase 1/2 STAAR study of ST-920. The Company expects to also pursue regulatory approval of ST-920 outside of the United States.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | | Description |
99.1 | Press Release, dated September 21, 2026 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 21, 2026 | By: | /s/ Pierre Gravier |
Name: | Pierre Gravier | |
Title: | Chief Financial Officer | |