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HOPE-3

PharmaDeviceNews HOPE-3
Capricor Therapeutics’ deramiocel remains under active FDA review after the regulator agreed to consider 24-month HOPE-3 data, with the company now focusing its Duchenne muscular dystrophy case on preservation of upper limb skeletal muscle function. Representative image.
Pharma & Biotech

Capricor plans deramiocel BLA amendment with 24-month HOPE-3 data

Capricor Therapeutics says the United States Food and Drug Administration (FDA) is willing to review an amendment containing 24-month HOPE-3 data for deramiocel, keeping the experimental Duchenne muscular dystrophy cell therapy under active consideration despite a strongly negative advisory committee vote. The company intends to narrow the regulatory case from Duchenne-associated cardiomyopathy to preservation of

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Representative image: Clinicians review heart imaging and Duchenne muscular dystrophy trial data as Capricor Therapeutics’ $CAPR deramiocel faces heightened FDA uncertainty following a 9 to 3 advisory committee vote against its cardiomyopathy evidence.
Pharma & Biotech

Conflicting HOPE-3 analyses divide FDA panel over deramiocel in Duchenne muscular dystrophy

FDA advisers voted 9 to 3 against deramiocel’s Duchenne cardiomyopathy evidence after challenging the Phase 3 analysis and trial population.

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