Capricor Therapeutics rose after Oppenheimer upgraded the biotech to Outperform from Perform, citing a regulatory update that extended the FDA’s review deadline for its Duchenne muscular dystrophy treatment, deramiocel.
The analyst firm raised its price target to $54 from $38, while Cantor Fitzgerald lifted its target to $28 from $3.50. Capricor’s shares were indicated at $6.80, down 76% over the prior six months despite the upgrades. The company’s market capitalization stands at $395 million.
The FDA accepted a major amendment to the biologics license application, moving the Prescription Drug User Fee Act (PDUFA) target date to November 22, 2026. The agency may consider an indication for Duchenne based on upper limb function, aligning with the Phase 3 HOPE-3 study’s primary endpoint. The advisory committee had voted 9 against and 3 in favor of the treatment’s benefit-risk profile.
Capricor reported a second-quarter loss of $0.70 per share, wider than the $0.60 loss expected, with no revenue recorded. Management plans to disclose 24-month open-label extension data from the HOPE-3 study and additional details ahead of the PDUFA date.
