Why Is Capricor Therapeutics Stock Trading Lower On Monday?

Capricor Therapeutics, Inc. CAPR stock is trading lower on Monday, with a session volume of 1.9 million compared to an average volume of 2.41 million, as per data from Benzinga Pro.

According to a Friday media report, Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), canceled the advisory committee meeting for the company's cell therapy for Duchenne muscular dystrophy.

Also Read: Capricor Reports 4-Year Data For Deramiocel, Shows Sustained Benefit In Duchenne Patients

Earlier in June, the FDA’s Pre-License Inspection (PLI) of its San Diego manufacturing facility for Deramiocel, the company’s lead cell therapy candidate with a Biologics License Application (BLA) under FDA review for potential approval in the treatment of Duchenne Muscular Dystrophy (DMD).

The FDA informed Capricor of its intent to hold the Advisory Committee meeting on July 30, 2025, although that date is pending confirmation by the FDA. At the time of the mid-cycle review, no significant issues or major deficiencies were noted.

The BLA for Deramiocel remains under priority review with a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025.

STAT News reported that the FDA removed its top official overseeing cell and gene therapies shortly after a dispute with her superior over a treatment for Duchenne muscular dystrophy.

The official, Nicole Verdun, had planned to convene an advisory committee meeting to evaluate a therapy developed by Capricor Therapeutics. However, to STAT, Prasad — her superior — doubted the treatment's effectiveness and canceled the meeting, citing sources familiar with the matter.

The report also noted that some sources described ongoing tensions surrounding Verdun's management style, adding uncertainty about the reasons she was placed on leave.

Since the report on Friday, Capricor stock has plunged almost 30%.

Alliance for Regenerative Medicine (ARM), an advocacy organization, said with five regulatory decisions pending on cell and gene therapy (CGT) products in 2025 and a burgeoning pipeline of nearly 2,000 CGT clinical trials ongoing globally, CBER and OTP must operate at the highest level of productivity, efficiency, and scientific rigor.

Price Action: CAPR stock is down 11.6% at $7.30 at the last check on Monday.

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