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Capricor reports Q1 2026 loss, FDA review of Duchenne muscular dystrophy drug Deramiocel ongoing with launch preparations underway

Company Fundamentals
12 May 2026
GlobeNewsWire
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Bullish
pluang ai news

Capricor Therapeutics reported a net loss of $33.9 million for Q1 2026 as it advances its Duchenne muscular dystrophy treatment, Deramiocel, which is under active FDA review with a PDUFA date set for August 22, 2026. The company is preparing for commercial launch with an operational GMP manufacturing facility and plans to expand capacity by 2027. Legal action was taken against its distributor NS Pharma to resolve pricing and access issues, but this does not affect the FDA review timeline. Capricor holds about $279 million in cash, expected to fund operations through late 2027, and may receive a Priority Review Voucher upon approval, providing potential additional capital.

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