Capricor announces publication of HOPE-3 data in The Lancet
The peer-reviewed results show a 54% slowing of upper limb decline and cardiac benefit in Duchenne patients.
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Biotechnology company developing cell and exosome-based therapeutics
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In short: Capricor Therapeutics shares plummeted after an FDA advisory committee voted 9-3 against the effectiveness of its DMD therapy, Deramiocel.
The peer-reviewed results show a 54% slowing of upper limb decline and cardiac benefit in Duchenne patients.
Capricor responds to FDA briefing materials, highlighting HOPE-3 trial results and statistical plan differences ahead of the July 29 advisory committee meeting.
The meeting is on July 29, 2026, and the PDUFA date is August 22, 2026.
The data show durable skeletal and cardiac muscle benefit with a favorable safety profile over five years.
After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior motive...
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