The FDA review of Deramiocel remains ongoing and could eventually lead to the assignment of a new PDUFA decision date.
- Late-breaking Phase 3 results will be presented at the Muscular Dystrophy Association conference on March 11 in Orlando.
- Regulatory review for Deramiocel is ongoing, with the FDA requesting the full Hope-3 clinical study report as part of its review.
- The Hope-3 trial previously reported positive topline results, showing a slower decline in upper limb function and improved cardiac performance.
Shares of Capricor Therapeutics, Inc. (CAPR) drew heightened retail buzz on Thursday as investors weighed the company’s upcoming reveal of Phase 3 Duchenne muscular dystrophy (DMD) data next week, which will highlight muscle and cardiac benefits from its cell therapy Deramiocel.
CAPR stock posted its third straight day of losses in Wednesday’s regular session, slipping more than 1% to close at $25.5, though shares rebounded in extended trading, rising over 2% after-hours.
Hope-3 Trial Heads To MDA 2026
Capricor said results from its Phase 3 Hope-3 study will be presented in a late-breaking oral session at the Muscular Dystrophy Association Clinical and Scientific Conference on March 11 in Florida, with national principal investigator Craig McDonald scheduled to present the data.
DMD is a genetic disease that progressively weakens muscles and frequently leads to heart failure, making treatments that preserve both muscle and cardiac function particularly important.
Capricor CEO Linda Marban said, “The selection of Hope-3 as a late-breaking presentation at the MDA Conference recognizes the strength and growing body of clinical evidence supporting Deramiocel and its potential impact for patients living with Duchenne.”
CAPR Moves Ahead In FDA Process
The conference presentation comes as the therapy continues through the U.S. Food and Drug Administration (FDA) regulatory review. In January, Capricor said the FDA formally requested the full clinical study report from the Hope-3 trial as part of the ongoing review of the company’s biologics license application for Deramiocel.
The company said the report will address items outlined in a Complete Response Letter issued in July 2025. Capricor added that the submission allows the FDA to continue evaluating the therapy and could lead to the assignment of a new Prescription Drug User Fee Act (PDUFA) target action date.
Notably, the FDA did not request any additional clinical trials or new patient data during the review.
Phase 3 Hope-3 Meets Primary Goal
Capricor reported positive topline results from the Hope-3 study in December. The Phase 3 trial met its primary endpoint by demonstrating a statistically significant slowing in the decline of upper limb function in patients with Duchenne muscular dystrophy. The therapy also showed improvement in a key cardiac measure known as left ventricular ejection fraction.
The study enrolled 106 boys and young men with Duchenne, including patients who can no longer walk. Capricor said the therapy demonstrated benefits across both skeletal muscle and cardiac outcomes while maintaining a safety profile consistent with earlier studies.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment for CAPR was ‘bearish’ amid a nearly 50% jump in 24-hour message volume.
One user noted that the stock’s relatively small free float makes price swings more likely, adding that once news flow and trading volume increase, the situation could change quickly.
Another user said, “CAPR is my only red today, and honestly, I don't even mind. I know it’ll take off again in no time, so it’s all good.”
CAPR stock has declined 12% year-to-date.
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