CAPRICOR THERAPEUTICS, INC. 8-K

What Happened
Capricor Therapeutics, Inc. (CAPR) announced in an 8-K filed June 26, 2026 that the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 29, 2026 to review the company’s Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD). The company said the meeting will be live-streamed and that the BLA remains on track for a PDUFA target action date of August 22, 2026. A press release was filed as Exhibit 99.1.

Key Details

• Advisory Committee: Cellular, Tissue, and Gene Therapies Advisory Committee (FDA).
• Meeting date: July 29, 2026; available via live stream.
• Regulatory timeline: BLA target PDUFA action date of August 22, 2026.
• Program: Deramiocel — investigational cell therapy for Duchenne muscular dystrophy (DMD).
• Filing: 8-K dated June 26, 2026; press release attached as Exhibit 99.1.

Why It Matters
An FDA advisory committee meeting is a major regulatory milestone and a near-term catalyst for Capricor: the committee’s review and discussion can influence the FDA’s final decision on the BLA ahead of the PDUFA date. Investors should view the July 29 meeting and the August 22 PDUFA date as key upcoming events that could materially affect the company’s regulatory outlook and market reaction.