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Stock impact report

Capricor outlines deramiocel PDUFA date of August 22, 2026 while targeting 2,000 to 2,500 patients per year manufacturing capacity [Seeking Alpha]

Capricor Therapeutics, Inc. (CAPR) 
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: capricor.com/investors
Company Research Source: Seeking Alpha
Linda Marbán said the “most significant development” is that “our biologics license application, or BLA, for deramiocel is currently under active review by the FDA with a PDUFA target action date of August 22, 2026,” adding that Newsletters for Every Investor Get daily, sector-specific newsletters packed with expert insights, fresh ideas, and new opportunities. Subscribe to Newsletters Sign Up Quick Insights Capricor is shifting from supporting NS Pharma to preparing for an independent launch, citing the lawsuit's aim to regain control due to unworkable pricing. The lawsuit creates legal and timing uncertainties, but management states the FDA review timeline is unaffected. Deramiocel's biologics license application is under FDA review with active information requests. HOPE-3 met efficacy endpoints, and Capricor expects near-term labeling discussions. Manufacturing planning and some launch steps depend on FDA label guidance. Capricor reported $279 million in liquidity, Show less Read more
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