FDA Extends Deramiocel PDUFA Date to November 22 After Major Amendment
CAPR has more than doubled off its 52-week low of $2.96.
Summary
The FDA extended the PDUFA target action date for Capricor's Deramiocel BLA by three months to November 22, 2026, after classifying the company's submission of additional Phase 3 HOPE-3 data as a major amendment. The amendment includes 24-month open-label extension data and robustness analyses supporting a refined indication focused on upper limb function. This follows the July 29 advisory committee's 9-3 vote against deramiocel's effectiveness data, making the extension a setback that delays any potential approval. The company's stock surged 118% premarket on August 14 after the FDA agreed to review the new data, but this extension signals the agency needs more time to evaluate the additional information. The refined indication narrows the target population, which could reduce the commercial opportunity if approved. Investors should watch for further FDA communications and the November 22 decision date.
At the time of this announcement, CAPR was trading at $6.89 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $365.7M. The 52-week trading range was $2.96 to $40.37. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.