FDA Sets August 22 PDUFA Date for Capricor's Lead Drug Deramiocel, Advisory Committee Meeting Planned
CAPR has more than doubled off its 52-week low of $4.3.
Summary
Capricor Therapeutics announced the FDA has set August 22, 2026, as the PDUFA target action date for its Deramiocel Biologics License Application (BLA) for Duchenne Muscular Dystrophy. An FDA Advisory Committee Meeting will also be held to review the BLA. This follows the company's Q1 report in May, which confirmed the Deramiocel BLA was under active FDA review. Earlier today, Capricor also announced positive five-year data from its HOPE-2 Open-Label Extension study for Deramiocel. The PDUFA date provides a firm deadline for the FDA's decision on the company's lead drug, creating a significant binary event for the stock. The Advisory Committee Meeting indicates the FDA seeks expert opinion, which is a critical step in the review process. The FDA Advisory Committee Meeting will occur before the August 22 PDUFA date, and its outcome will be closely watched.
At the time of this announcement, CAPR was trading at $25.92 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.5B. The 52-week trading range was $4.30 to $40.37. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.