CAPR Stock Eyes 1st Weekly Gain In 5 Weeks: Capricor’s DMD Therapy Faces FDA Panel Review Next Week, Retail Sees 'Excellent Opportunity'

The Food and Drug Administration’s Advisory Committee is scheduled to meet on July 29 to review Capricor’s Biologics License Application for Deramiocel.

• The FDA has set a Prescription Drug User Fee Act target action date of Aug. 22, 2026.
• The application is backed by data from the Phase 2 Hope-2 trial and the Phase 3 HOPE-3 trial.
• Earlier, Capricor said it has enough funds for operations through the fourth quarter of 2027.

Shares of Capricor Therapeutics (CAPR) were in focus in pre-market trading on Wednesday as investors looked ahead to the U.S. Food and Drug Administration’s (FDA) upcoming Advisory Committee meeting for the company's investigational Duchenne muscular dystrophy (DMD) therapy, Deramiocel. The regulatory review comes just weeks before the FDA’s approval deadline in August. 

CAPR stock, which was down around 1% at the time of writing, is on track for its first weekly gain in five weeks. It has slumped around 30% over the past month.

FDA Panel Puts Capricor’s Lead Therapy In The Spotlight

The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is scheduled to meet on July 29 to review Capricor’s Biologics License Application (BLA) for Deramiocel. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 22, 2026. 

A PDUFA date is the deadline by which the FDA decides whether to approve a drug for marketing in the United States.

The application is backed by data from the Phase 2 Hope-2 trial and the Phase 3 HOPE-3 trial. Last month, Capricor announced that the Hope-3 trial met its primary endpoint, which measured upper-limb function, as well as its key secondary cardiac endpoint.

What Does Retail Think Of CAPR?

Retail sentiment surrounding CAPR on Stocktwits turned ‘neutral’ from ‘bullish’ a day earlier, amid a 48% increase in message volumes. The stock has been the talk of the town lately, with message volumes surging over 1,100% over the past 30 days.

One user said the committee meeting presents an “excellent opportunity” for the firm by bringing the review into the public eye instead of leaving the decision largely to the FDA’s internal BLA review process and private discussions with the company.

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However, not all investors were bullish; one user expected the stock to decline below $10 ahead of next week’s meeting.

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Deramiocel Holds Strong Potential in Europe

Deramiocel has received several regulatory incentives, including Orphan Drug Designation (ODD) from both the FDA and European Medicines Agency, Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation, which could qualify the company for a Priority Review Voucher.

Meanwhile, Capricor ended the first quarter with $278.6 million in cash, cash equivalents, and marketable securities, which it expects will fund operations through the fourth quarter of 2027.

The stock has fallen 30% so far this year.

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