NasdaqCM:CAPRBiotechs
Does FDA’s No-New-Trial Stance on Deramiocel Shift the Bull Case for Capricor Therapeutics (CAPR)?
Capricor Therapeutics recently issued a regulatory update on its Biologics License Application for Deramiocel in Duchenne muscular dystrophy, confirming that the FDA has requested the full Phase 3 HOPE-3 clinical study report and supporting data, but no new clinical trials or patient data.
The absence of a request for additional studies, combined with Capricor’s plan to submit the HOPE-3 report in February 2026, places the focus squarely on data interpretation and the potential for a new...