FDA Agrees to Review New Duchenne Drug Data, Capricor Shares Double
CAPR has more than doubled off its 52-week low of $2.96 on elevated volume (5.4× avg).
Summary
Capricor shares surged 118% premarket after the FDA agreed to review new 24-month data on deramiocel's upper limb muscle function, the main goal of its late-stage Duchenne study. This follows last month's 9-3 advisory committee vote against the drug's effectiveness, which had crushed the stock. The FDA will extend its August 22 decision deadline once the amendment is submitted, signaling a potential path forward. CEO Linda Marban said the muscle-function results remain statistically and clinically significant. Cantor analyst Kristen Kluska called the FDA's willingness to review the new data a 'potentially positive surprise,' noting the agency would have little reason to extend the deadline if it had already decided against approval. Watch for the amended submission and the new PDUFA date.
At the time of this announcement, CAPR was trading at $9.15 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $243.8M. The 52-week trading range was $2.96 to $40.37. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.