Capricor updates Deramiocel BLA status and HOPE-3 data
The FDA decision date is extended to Nov 22, 2026. The company submitted a major amendment with new robustness analyses and an Integrated Summary of Efficacy.
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Biotechnology company developing cell and exosome-based therapeutics
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In short: Capricor’s Deramiocel review was extended to November 2026 after it submitted additional data.
The FDA decision date is extended to Nov 22, 2026. The company submitted a major amendment with new robustness analyses and an Integrated Summary of Efficacy.
Cash at $238M, net loss widened to $40.7M, FDA advisory committee voted against, but HOPE-3 published in The Lancet.
The biotech reports a net loss of $40.7 million while advancing Deramiocel's BLA review with significant clinical data published in The Lancet.
The peer-reviewed results show a 54% slowing of upper limb decline and cardiac benefit in Duchenne patients.
According to data from Koyfin, four of the 10 analysts covering CAPR rate it Buy or higher, while six rate it Hold. Advertisement|Remove ads. Shares...
What is deramiocel being developed for? Deramiocel is an investigational allogeneic cardiosphere-derived cell therapy being developed by Capricor Therapeutics to treat Duchenne muscular dystrophy, with...
Capricor Therapeutics (NASDAQ: CAPR) presented data from the HOPE-3 open-label extension study showing that patients with Duchenne muscular dystrophy (DMD) who switched from placebo to...
The longer-term findings build on the randomized 12-month HOPE-3 results. The Phase 3 study met its primary endpoint, with deramiocel slowing deterioration in upper-limb function...
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