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FDA Committee Votes Down Duchenne Drug

Agency staff and drug developer disagree on endpoints

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medpagetoday.comStai leggendo11 h fa

FDA Committee Votes Down Duchenne Drug

Agency staff and drug developer disagree on endpoints

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biopharmadive.com1 g fa

Capricor Duchenne cell therapy voted down by FDA panel

At a contentious meeting with possible implications for other rare disease drugmakers, outside experts ultimately determined that Capricor didn't prove deramiocel's benefits in Duchenne-related cardiomyopathy.

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Timeline cronologica

lunedì 27 luglio 2026·statnews.com
Ahead of hearing, FDA questions the efficacy of Capricor's Duchenne drug
Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
lunedì 27 luglio 2026·medpagetoday.com
FDA Scientists Raise Questions About Duchenne Drug
Agency says deramiocel did not meet phase III trial endpoints, contrary to reported data

FDA Committee Votes Down Duchenne Drug

Confronto fonti

FDA Committee Votes Down Duchenne Drug

Capricor Duchenne cell therapy voted down by FDA panel

Timeline cronologica

Ahead of hearing, FDA questions the efficacy of Capricor's Duchenne drug

FDA Scientists Raise Questions About Duchenne Drug

Ahead of hearing, FDA questions the efficacy of Capricor's Duchenne drug

FDA and Capricor clash over deramiocel efficacy data at Duchenne adcomm vote

Capricor shares plunge after FDA says DMD therapy lacks efficacy ahead of adcomm

Capricor Duchenne cell therapy voted down by FDA panel

FDA expert panel recommends against approval of Capricor’s Duchenne drug

FDA Committee Votes Down Duchenne Drug

FDA and Capricor clash over deramiocel efficacy data at Duchenne adcomm vote