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 29, 2023, the Company announced a positive outcome from a Type-B clinical meeting with the U.S. Food and Drug Administration (the “FDA”) on the design and execution of HOPE-3, the Phase 3 pivotal trial of CAP-1002 in Duchenne Muscular Dystrophy (“DMD”). Feedback from the FDA on the proposed key clinical and regulatory requirements confirms CAP-1002’s path towards Biologics License Application (“BLA”) submission.
A copy of the press release has been filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 8.01 | Other Events. |
As disclosed above under Item 7.01, on September 29, 2023, the Company announced a positive outcome from a Type-B clinical meeting with the FDA on the design and execution of HOPE-3, the Phase 3 pivotal trial of CAP-1002 in DMD. Because the Company plans to submit a BLA for CAP-1002 in 2025 supported by results using product manufactured from the Los Angeles site, and not from the Company’s San Diego manufacturing site, the Company intends to focus significant time and resources on additional work needed at the Los Angeles site (which is leased under a facilities lease previously disclosed by the Company) to support the BLA submission. The Company will also continue work on its San Diego site with a view toward supporting potential increased commercial demand, subject to the FDA’s approval of the CAP-1002 product for treatment of DMD and its approval of the San Diego site.
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: September 29, 2023 | By: | /s/ Linda Marbán, Ph.D. |
Linda Marbán, Ph.D. | ||
Chief Executive Officer | ||
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