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• Capricor’s Deramiocel has already faced setbacks: a 2025 complete response letter for insufficient evidence, followed by a July advisory committee vote of 9-3 against the strength of evidence on heart benefits.
• H.C. Wainwright acknowledged the extension and the refined focus on upper-limb function, but reiterated its high-risk profile following the negative advisory vote.
• The key remaining question, the firm said, is whether the new 24-month data and analyses are enough to overcome the FDA’s earlier concerns.

Shares of Capricor Therapeutics (CAPR) closed 8% higher on Monday after the company announced a three-month U.S. Food and Drug Administration (FDA) extension of the decision deadline for its Duchenne muscular dystrophy cell therapy. Yet H.C. Wainwright remains unconvinced, sticking with a ‘Neutral’ rating and flagging the still-high risk of rejection.

FDA Grants Three-Month Review Extension

Capricor said the agency pushed the deadline to decide on the company’s application for deramiocel from August 22 to November 22. The move follows Capricor’s submission of a major amendment to its biologics license application. The update includes 24-month open-label extension data from the late-stage HOPE-3 trial, plus additional analyses to support a narrower proposed use focused on preserving upper-limb function.

The FDA’s biologics center accepted the package, citing the significant unmet need in Duchenne, a progressive muscle-wasting disease that primarily affects boys. CEO Linda Marbán called the longer-term data “one of the most extensive clinical datasets” on upper-limb function and said the company remains engaged with the agency.

Capricor’s Deramiocel has already faced setbacks: a 2025 complete response letter for insufficient evidence, followed by a July advisory committee vote of 9-3 against the strength of evidence on heart benefits. Panel members also questioned how the trial data were analyzed. The application has since shifted toward the upper-limb results from HOPE-3, which the company says met its primary endpoint.

Analyst Still Cautious

H.C. Wainwright acknowledged the extension and the refined focus on upper-limb function, but reiterated its high-risk profile following the negative advisory vote. The key remaining question, the firm said, is whether the new 24-month data and analyses are enough to overcome the FDA’s earlier concerns and clear the way for approval of the narrower indication. Wainwright kept its Neutral rating on the stock.

How Did CAPR Retail Traders React?

On Stocktwits, retail sentiment around CAPR stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.

A Stocktwits user noted that the FDA approval for Deramiocel could come before November 22 as well.

Another user, however, opined that the company is stalling an impending rejection.

“So happy to see that FDA finally came to their senses and extended the PDUFA...,” a third user wrote. They further pinned the delays to Deramiocel approval to the former Director of the Center for Biologics Evaluation and Research, Vinay Prasad, who stepped down earlier this year following criticism for the FDA’s decisions on multiple vaccine reviews.

CAPR stock has lost 76% year-to-date. 

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