Capricor: FDA adcomm set for Deramiocel BLA in DMD on July 29, 2026

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will convene on July 29, 2026 to review Capricor's BLA for Deramiocel in Duchenne muscular dystrophy. The meeting precedes the PDUFA target action date of August 22, 2026. The BLA is supported by Phase 2 HOPE-2, HOPE-2-OLE, and Phase 3 HOPE-3 trial data.

Key facts

Filed: Jun 26, 2026, 09:15 PM
Event: Advisory committee scheduled
Direction: Neutral
Company: CAPRCapricor
Asset: Deramiocel
Source: SEC 8-K
Confidence: Sourced
Calendar: Advisory committee · Jul 29, 2026 · Negative

Source excerpt

EX-99.1 2 capr-20260626xex99d1.htm EX-99.1 Exhibit 99.1 Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy –Advisory Committee meeting scheduled for July 29, 2026– –Company's Biologics License Application on track with PDUFA target action date of August 22, 2026– SAN DIEGO , June 26, 2026 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) of the U.S. Food and Drug Administration (FDA) is planning to convene an advisory committee meeting to discuss the Company's Biologics License Application (BLA) seeking approval of Deramiocel, an investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). The BLA is supported by the Company's Phase 2 HOPE-2 trial and long-term outcomes from the HOPE-2-OLE trial, as well as positive results from the Phase 3 HOPE-3 trial , which achieved statistical significance on its primary endpoint (PUL v2.0), the key secondary cardiac endpoint (LVEF), and all other Type I error-controlled secondary endpoints. The date for the Advisory Committee meeting is July 29, 2026, and the meeting will be available for live streaming. "We are encouraged by the opportunity to bring Deramiocel before the Advisory Committee and engage directly with the FDA, t

SEC 8-K