Capricor Therapeutics rockets on plan to file BLA for full approval of deramiocel

US biotech Capricor Therapeutics (Nasdaq: CAPR) saw its shares leap more than 31% to $7.82 by mid-morning on positive development for its deramiocel.

Capricor said that, following recent meetings with the US Food and Drug Administration (FDA), it intends to file a Biologics License Application (BLA) based on existing cardiac and natural history data for deramiocel to treat all patients diagnosed with Duchenne muscular with Duchenne muscular dystrophy (DMD) cardiomyopathy.

· Capricor plans to commence the filing of a BLA in October of 2024 seeking full approval of deramiocel for the treatment of DMD-cardiomyopathy with full submission expected by year-end 2024.

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