What’s Going On With Capricor Therapeutics Stock On Friday?

Capricor Therapeutics Inc. (NASDAQ:CAPR) stock is trading lower on Friday, down by 13%.

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 Duchenne muscular dystrophy (DMD).

FDA Sets Advisory Committee Meeting For Capricor Deramiocel

The BLA is supported by the 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.

“We are encouraged by the opportunity to bring Deramiocel before the Advisory Committee and engage directly with the FDA, the DMD patient community, and the physicians who care for them,” said Linda Marbán, CEO of Capricor.

FDA Reconsiders Multiple Cell And Gene Therapy Applications

Capricor stock is trading lower as investors probably react to the additional step (adcom meeting) for its Duchenne gene therapy before the final FDA decision.

Several controversial decisions marked Dr. Vinay Prasad’s tenure at the FDA. After his departure, the agency has started reconsidering some of the decisions.

In May, Replimune Group Inc. (NASDAQ:REPL) said that the company and the FDA aligned on a path forward for resubmission and reconsideration of BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma.

Earlier this week, Regenxbio Inc. (NASDAQ:RGNX) said it aligned with the FDA regarding the next steps needed for a potential accelerated approval of Navsunli (RGX-121, clemidsogene lanparvovec).

Last week, uniQure N.V. (NASDAQ:QURE) announced plans for a BLA submission for AMT-130, a gene therapy treatment for Huntington’s disease.

Last week, Moderna Inc. (NASDAQ:MRNA), a key FDA panel voted unanimously in favor of the benefit-risk profile of its experimental seasonal influenza vaccine, clearing a major regulatory hurdle ahead of a final approval decision in August.

CAPR Price Action: Capricor Therapeutics shares were down 12.75% at $26.52 at the time of publication on Friday, according to Benzinga Pro data.

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