CAPR Stock on Track For Worst Month Since July AdCom Vote On Deramiocel As November FDA Decision Nears

The FDA is slated to decide on approving Capricor’s Deramiocel for the treatment of Duchenne muscular dystrophy by November 22.

• CAPR shares are now on track to clock the third consecutive week in the red, if the losses hold.
• Earlier this month, H.C. Wainwright said that it only sees a small chance of approval for the therapy and noted that it sees a rejection as a more likely outcome.
• According to data from Koyfin, four of the 10 analysts covering CAPR rate it Buy or higher, while six rate it Hold.

Shares of Capricor Therapeutics (CAPR) fell 11% on Wednesday, extending weeks of decline, as investors weighed the odds of an approval from the U.S. Food and Drug Administration for the company’s lead therapy Deramiocel.

The FDA is slated to decide on approving the drug for the treatment of Duchenne muscular dystrophy by November 22. Duchenne muscular dystrophy (DMD) is a rare, inherited genetic disorder that causes progressive muscle degeneration and weakness that presents predominantly in young boys.

CAPR shares are now on track to clock the third consecutive week in the red, if the losses hold. So far this month, the stock has dropped about 38%, on track for its worst month since July, when an FDA advisory committee voted against the effectiveness of the drug.

Capricor’s Rocky Road Towards Approval

Capricor initially sought approval for cardiomyopathy associated with the disease. 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 late-stage 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.

Wall Street Weighs In On CAPR

Wall Street is divided on whether FDA will approve the drug. Earlier this month, H.C. Wainwright said that it only sees a small chance of approval for the therapy and noted that it sees a rejection as a more likely outcome. Roth Capital, meanwhile, said it views a second FDA panel focusing on upper-limb preservation in Duchenne muscular dystrophy patients as a possibility given that the first panel voted on deramiocel's effectiveness in DMD cardiomyopathy.

According to data from Koyfin, four of the 10 analysts covering CAPR rate it Buy or higher, while six rate it Hold. The 12-month average price target on the stock is $27, representing a potential upside of over 300% from the stock’s last closing price on Tuesday.                              

How Did CAPR Retail Traders React?

On Stocktwits, retail sentiment around CAPR stock fell from extremely bullish to bullish territory over the past 24 hours, while message volume fell from extremely high to high levels.

A Stocktwits user said that they are adding more shares of the company in light of the selloff.

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Another said that they are about to lose a year's worth of savings on the stock.

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A third user opined that even if the drug were to get approved, it would only hit $10, and not higher.

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CAPR stock fell about 80% year-to-date.

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