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

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.

• 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,” CEO Linda Marban said on the company’s earnings call. 
• Marbán added on Tuesday that the company's application with the FDA is in its final review stages.

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.

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 Seeks FDA Approval With Revised Deramiocel Label

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 trial’s primary endpoint—preservation of upper-limb function—rather than cardiomyopathy. The agency treated that package as a major amendment and moved the decision to November 22.

Marbán said on Tuesday that the company's application with the FDA is in its final review stages. The company, in the meantime, is advancing launch preparations while pacing spending to the regulatory timeline.

Management said the company’s San Diego GMP facility is operational and capable of supporting an initial launch volume sufficient for roughly 250 patients annually. It added that a second-floor expansion targeted for validation in the first half of 2027 is expected to support 2,000–2,500 patients.

Capricor continues to pursue independent commercialization amid an ongoing arbitration with Nippon Shinyaku’s unit NS Pharma, with whom the company had initially inked a deal for distribution of the drug. Management does not expect the dispute to delay patient access if Deramiocel is approved.

How Did CAPR Retail Traders React?

On Stocktwits, retail sentiment around CAPR stock stayed within the 'extremely bullish' territory over the past 24 hours, while message volume stayed at 'extremely high' levels.

A Stocktwits user opined that management commentary implies there is labeling discussion underway and voiced hopes for approval of Deramiocel for preservation of upper limb function nonetheless.

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Another user opined that the FDA may grant a post-marketing, conditional approval for the cardiomyopathy claim, with later data serving as confirmation.

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Others opined that while there is still risk of rejection from the FDA, it is “albeit less” than before the earnings call. Some also highlighted that the company is hiring for multiple new roles in anticipation of Deramiocel’s launch.

Among other roles, the company’s job board showed an opening for a senior director of commercial operations who will be responsible for supporting the company’s anticipated U.S. launch of Deramiocel.

CAPR stock has dropped 63% year-to-date.

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