Capricor Therapeutics Inc. (NASDAQ: CAPR) surged 15.7% on Tuesday after Oppenheimer upgraded the stock to Outperform from Perform, citing regulatory progress for its lead candidate deramiocel.
The upgrade reflects an FDA decision to accept additional material submitted since last month’s advisory committee meeting as a major amendment, moving the Prescription Drug User Fee Act (PDUFA) target date to November 22. Oppenheimer analyst Leland Gershell also highlighted the agency’s potential consideration of an upper limb function-based Duchenne muscular dystrophy (DMD) indication, aligning with the Phase 3 trial’s primary endpoint. Gershell noted that efficacy signals for the upper limb function endpoint appear clearer than those observed for cardiomyopathy.
Capricor CEO Linda Marbán said the company plans to disclose 24-month data from the HOPE-3 open-label extension study ahead of the PDUFA date. She added that additional submissions to the FDA are also expected in the coming months.
Gershell stated that the upgrade reflects a reassessment of deramiocel’s approval prospects, with shares likely to continue climbing as market sentiment improves. The new price target was set at $54, up from the prior level.
