CAPR Stock Rallies After-Hours As Capricor Reaffirms Deramiocel Confidence Ahead Of Nov. 22 Decision; Says Application In Final Review

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

• CEO Linda Marbán said on the company’s earnings call that the company's Biologics License Application is in its final review stages.
• The company, in the meantime, is advancing launch preparations while pacing spending to the regulatory timeline.
• 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.

Capricor Therapeutics (CAPR) used its third-quarter earnings call on Tuesday to reaffirm its confidence in its therapy deramiocel for Duchenne muscular dystrophy as the FDA’s November 22 target action date approaches.

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.

CEO Linda Marbán said on the company’s earnings call that the company's Biologics License Application is in its final review stages. The company, in the meantime, is advancing launch preparations while pacing spending to the regulatory timeline. Its San Diego GMP facility is operational and capable of supporting an initial launch volume sufficient for roughly 250 patients annually; a second-floor expansion targeted for validation in the first half of 2027 is expected to support 2,000–2,500 patients, management said.

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.

CAPR stock rose 5% after hours on Tuesday following the call. The stock closed the regular session 10% lower.

Capricor’s Rocky Road With Deramiocel

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 Nov. 22.

Marbán highlighted on Tuesday that HOPE-3 met its primary endpoint, showing a statistically significant 1.1-point difference versus placebo on the scale meant to gauge upper limb function.

“We do not believe that this is a case that rests solely on unmet medical need, secondary endpoints, or regulatory flexibility,” Marbán told analysts. “HOPE-3 met its primary efficacy endpoint. The long-term data show the same trajectory.”

Capricor is still in the clinical stage and reported no revenue and a net loss of $42.7 million, or $0.73 per share, for the third quarter, wider than the $24.6 million loss a year earlier. Operating expenses rose to $44.7 million from $26.3 million, driven by pre-commercial activities and manufacturing scale-up. The company also reduced its workforce by about 10% in the quarter.

Cash, cash equivalents, restricted cash, and marketable securities stood at approximately $198.5 million as of September 30, which management said is sufficient to fund operations for at least the next 12 months.

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 jumped from 'high' to 'extremely high' levels.

A Stocktwits user said that they now see 95% chances of approval for Deramiocel.

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Another more cautious user said that they would rather still gear up for a rejection.

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CAPR stock has dropped 69% year-to-date. 

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