UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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The |
Item 8.01Other Events.
On August 24, 2026, Capricor Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has extended the Prescription Drug User Fee Act (“PDUFA”) target action date for its Biologics License Application (“BLA”) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy ("DMD"), from August 22, 2026 to November 22, 2026. The FDA has classified the submission as a major amendment, which extends the review period by three months. The amendment includes 24-month open-label extension data from Capricor’s pivotal Phase 3 HOPE-3 study, and additional analyses with a request for FDA’s review of the existing and new data in support of a refined proposed indication focused on upper limb function, the primary endpoint of HOPE-3.
A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01Financial Statements and Exhibits.
(d) Exhibits
99.1 | ||
104 | Cover Page Interactive Data File (formatted as inline XBRL). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
CAPRICOR THERAPEUTICS, INC. | ||
Date: August 24, 2026 | By: | /s/ Linda Marbán, Ph.D. |
Linda Marbán, Ph.D. | ||
Chief Executive Officer | ||
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