Capricor Shares Rally 17% on FDA Resumption of Deramiocel Review
FDA resumed review of the BLA for Deramiocel and set an August 22, 2026 PDUFA date after lifting its July 2025 CRL following a Class 2 resubmission. Capricor shares surged 17.2% Tuesday, extending a rally from $4.60 in December to $35.80 in early March.
1. FDA Resumes Deramiocel Review
The FDA has lifted its July 2025 Complete Response Letter and resumed its review of Capricor’s Biologics License Application for Deramiocel, assigning a new PDUFA target action date of August 22, 2026. This resumption follows the submission of additional data and documentation as a Class 2 resubmission under the HOPE-3 Phase 3 trial.
2. HOPE-3 Resubmission and Trial Results
Capricor’s filing incorporated positive pivotal HOPE-3 results, with the therapy achieving its primary efficacy endpoint and all Type I error-controlled secondary endpoints. The data support Deramiocel’s potential as the first treatment targeting both skeletal and cardiac complications in Duchenne muscular dystrophy cardiomyopathy.
3. Stock Rally and Momentum Indicators
Capricor shares jumped 17.2% on the day of the announcement, extending a rally from a 52-week low of $4.60 in December 2025 to about $35.80 in early March 2026. The stock trades well above its 20-, 50- and 200-day moving averages, reflecting strong bullish momentum and heightened investor interest.