Capricor Shares Jump 9% on FDA Review Hopes; Q4 Results Call Set
Capricor shares rose 9.07% after FDA CBER head Vinay Prasad’s planned April resignation raised hopes for an accelerated review of its Deramiocel BLA following a July CRL citing insufficient efficacy data. The company will report fourth-quarter and full-year 2025 results on March 12 at 4:30 p.m. ET and host a conference call to discuss its financial performance and corporate update.
1. Prasad Departure and Stock Reaction
FDA CBER director Vinay Prasad will step down in April, prompting a 9.07% surge in Capricor shares as investors anticipate a less stringent review environment for rare disease therapies.
2. Deramiocel BLA and FDA CRL
In July, Capricor received a Complete Response Letter for its Deramiocel BLA, with regulators citing insufficient substantial evidence of effectiveness and requesting additional clinical data despite positive HOPE-3 topline results showing 54% skeletal disease progression slowdown and 91% cardiomyopathy benefit.
3. Upcoming Q4 and Full-Year Results Call
Capricor will publish its fourth-quarter and full-year 2025 financial results on March 12 at 4:30 p.m. ET, followed by a conference call and webcast to discuss revenue, R&D spending and strategic updates on pipeline advancement.