Capricor Therapeutics to Face FDA Advisory Panel on BLA for Deramiocel; PDUFA Aug 22

Capricor Therapeutics announced an FDA advisory committee meeting on July 29, 2026 to review its BLA for Deramiocel, with a PDUFA target action date of August 22, 2026.Key Highlights:Original SEC Filing: CAPRICOR THERAPEUTICS, INC. [ CAPR ] - 8-K - Jun. 26, 2026This is an AI-powered summary. It may…

Capricor Therapeutics announced an FDA advisory committee meeting on July 29, 2026 to review its BLA for Deramiocel, with a PDUFA target action date of August 22, 2026.

Key Highlights:

FDA's CTGTAC will hold an advisory committee meeting on July 29, 2026 to discuss the BLA for Deramiocel.
The BLA is supported by Phase 2 HOPE-2, HOPE-2-OLE long-term outcomes, and positive Phase 3 HOPE-3 results.
HOPE-3 achieved statistical significance on primary (PUL v2.0), key cardiac (LVEF), and other controlled secondary endpoints.
Meeting will be live streamed; Capricor's BLA remains on track for a PDUFA target action date of August 22, 2026.

Original SEC Filing:

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.