The U.S. Food and Drug Administration extended its review of the biotech firm’s experimental Duchenne muscular dystrophy treatment, Deramiocel, by three months.

  • Capricor submitted 24-month Hope-3 data to support approval focused on preserving upper-limb function.
  • The FDA’s Center for Biologics Evaluation and Research accepted the amendment, citing the significant unmet medical need in DMD.
  • The FDA postponed the therapy’s decision date from August 22 to November 22.

Capricor Therapeutics (CAPR) shares were in the limelight on Monday after the U.S. Food and Drug Administration (FDA) extended its review of the biotech firm’s experimental Duchenne muscular dystrophy treatment, Deramiocel, by three months.

At the time of writing, CAPR shares were up nearly 7%.

FDA Pushes Target Date To November 22

The FDA postponed the therapy’s decision date from August 22 to November 22 after accepting a major amendment to Capricor’s application that included new clinical data.

That means the agency did not issue a Complete Response Letter (CRL) by the original deadline. A CRL would have meant the treatment could not be approved in its current form. However, the extension does not guarantee approval or rule out a CRL when the FDA completes its review in November.

Capricor submitted 24-month follow-up data from the Phase 3 Hope-3 study, along with additional analyses supporting a narrower indication focused on preserving upper-limb function.

The FDA’s Center for Biologics Evaluation and Research accepted the amendment, citing the significant unmet medical need in DMD. Deramiocel is an experimental cell therapy designed to slow muscle damage caused by DMD, a rare genetic disease that leads to progressive weakness and often damages the heart.

Application Focuses On Upper Limb Function

Capricor said the Hope-3 study met its primary goal, showing a statistically significant benefit in upper-limb function. CEO Linda Marbán said the additional follow-up provides one of the most extensive datasets evaluating arm function in Duchenne patients.

“HOPE-3 met its primary endpoint, demonstrating a statistically significant benefit in upper limb function, and we believe the additional open-label data and further analyses included in the amendment strengthen the evidence supporting a refined proposed indication,” Marbán added.

Independent Panel Setback Raised Rejection Concerns

The extension provides Capricor with a path forward after an FDA advisory committee voted 9-3 that the available evidence did not support Deramiocel’s effectiveness in treating Duchenne-related cardiomyopathy. The panel’s recommendation was not binding, but it had raised concerns about approval.

By refining the proposed indication toward upper-limb function, Capricor shifted the review toward an area where its Phase 3 results were stronger.

The company received a CRL in July 2025 because the application did not provide sufficient evidence of effectiveness.

CAPR Bulls Eye $40

Retail sentiment for CAPR on Stocktwits remained in the ‘bullish’ territory over the past 24 hours.

One user said the probability of approval is higher and that if approved, CAPR would be a $40 stock. It is currently trading around $6.8

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Another user said the FDA could approve the therapy in one or two months.

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The stock is down 76% so far in 2026.

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