CAPR Stock Rallies: Investors Scrutinize Labeling Hints Before FDA Decision On Cell Therapy This Month

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The U.S. Food and Drug Administration is slated to decide on approving Capricor’s Deramiocel for the treatment of Duchenne muscular dystrophy by November 22.

Shares of Capricor Therapeutics (CAPR) jumped 20% on Wednesday, paring losses from the day before, following the company's third-quarter earnings call where management reiterated confidence in its Deramiocel trial data, pumping up investor optimism ahead of an FDA decision on its approval.

The U.S. Food and Drug Administration is slated to decide on approving Deramiocel for the treatment of Duchenne muscular dystrophy (DMD) by November 22.

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DMD is a rare, inherited genetic disorder that causes progressive muscle degeneration and weakness that presents predominantly in young boys. The company is seeking approval for Deramiocel to preserve upper-limb function in patients older than nine, but questions pertain as to whether the agency will also include any cardiomyopathy-related claims in its labeling were it to be approved.

"We are not disclosing the label information at this point. What I can tell you is I am very bullish personally and professionally on the cardiomyopathy data," CEO Linda Marban said on the company's earnings call after hours on Tuesday. "Whether it is in the label now or will be a future label expansion, it is something that we will update people on later. But the data is good, and patients deserve it."

Capricor initially sought approval for cardiomyopathy associated with DMD for Deramiocel. The company's first application was rejected in July 2025, citing a lack of substantial evidence of effectiveness. The company resubmitted the application earlier this year with HOPE-3 trial data, and the agency said it will decide on the application by August 22. However, an advisory committee met at the end of July and voted 9–3 that the evidence did not support effectiveness for cardiomyopathy.

Capricor then submitted additional 24-month clinical data analyses from the HOPE-3 trial and asked FDA to consider a refined label built on the…

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