09:54 AM EDT, 09/24/2024 (MT Newswires) -- Capricor Therapeutics ( CAPR ) said Tuesday it intends to start filing a biologics license application in October seeking full approval of deramiocel for the treatment of Duchenne muscular dystrophy cardiomyopathy.
Full submission is expected by the end of this year, the company said, noting that its intent to file the application follows recent meetings with the US Food and Drug Administration.
The filing will be based on existing cardiac and natural history data for deramiocel, the company said.
Capricor shares climbed 33% in recent Tuesday trading.
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