Capricor Therapeutics stock surges on Oppenheimer upgrade

Capricor Therapeutics Inc (NASDAQ: CAPR) shares experienced a significant 15.7% increase on Tuesday following an upgrade from Oppenheimer analyst Leland Gershall. The analyst raised the stock from Perform to Outperform, setting a price target of $54. This upgrade was prompted by regulatory updates from the FDA regarding the company's deramiocel treatment for Duchenne muscular dystrophy.

The FDA accepted material submitted since the last month's advisory committee meeting, which resulted in a new PDUFA (Preparatory and Developmental Uniformity Assessment) date of November 22. Gershall noted that the FDA's acceptance of the additional data may indicate that efficacy in treating Duchenne muscular dystrophy is more favorable compared to its cardiomyopathy indications.

Moreover, the agency might consider evaluating an upper limb function-based Duchenne indication, which aligns with the Phase 3 trial's primary endpoint. Capricor CEO Linda Marbán mentioned that the company intends to release 24-month HOPE-3 open-label extension data before the PDUFA date, as well as other information submitted to the FDA.

Gershell added that the shares are gradually rising as the market reassesses the approval prospects of deramiocel.