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Capricor Therapeutics, Inc. issued a press release on March 10, 2026, announcing under Item 7.01 that the FDA has lifted the previously issued CRL and resumed review of the Company’s BLA seeking full approval of Deramiocel, with a new PDUFA date established under Item 8.01.
Event Type
Disclosure
Voluntary
Variant
8-K
Regulation FD Disclosure. On March 10, 2026, Capricor Therapeutics, Inc. (the “Company” or “Caprcior”) issued a press release announcing that the U.S. Food an
Other Events. As disclosed above, the FDA has lifted the previously issued CRL and resumed review of the Company’s BLA seeking full approval of Deramiocel, an
Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release, titled “Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel