CAPR · Capricor Therapeutics, Inc.

Summary

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.

Key takeaways

• FDA lifted previously issued CRL for Deramiocel BLA
• FDA resumed review of BLA seeking full approval of Deramiocel
• New PDUFA date established for Deramiocel
• Press Release issued on March 10, 2026 as Exhibit 99.1