UNITED STATES
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FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On September 24, 2024, Capricor Therapeutics, Inc. (the “Company” or “Capricor”) announced its intent to file a Biologics License Application (“BLA”) supported by existing and natural history cardiac data for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (“DMD”) cardiomyopathy following its recent meetings with the U.S. Food and Drug Administration (“FDA”). The Company plans to initiate the rolling submission in October 2024. Furthermore, in order to support potential label expansion to treat DMD skeletal muscle myopathy, Capricor plans to combine Cohorts A and B of the Phase 3 HOPE-3 clinical trial to serve as a post-approval study and does not intend to unblind Cohort A at this time, which was expected to occur in the fourth quarter of 2024.
A copy of the press release and slide presentation has been filed as Exhibit 99.1 and Exhibit 99.2 hereto and is incorporated herein by reference.
The information under Item 7.01 of this Current Report on Form 8-K, Exhibit 99.1 and Exhibit it 99.2 attached hereto is being furnished and shall not be deemed to be 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 incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
Item 9.01Financial Statements and Exhibits.
(d) Exhibits
99.1 | ||
99.2 | Capricor Therapeutics, Inc. Slide Presentation, dated September 24, 2024. | |
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: September 24, 2024 | By: | /s/ Linda Marbán, Ph.D. |
Linda Marbán, Ph.D. | ||
Chief Executive Officer | ||
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