FDA and Capricor spar over HOPE-3 data at an adcomm for a Duchenne cell therapy, as The Lancet publishes results and families back the cell therapy.
July 29, 2026 02:11 PM EDT
FDA+
FDA and Capricor clash over deramiocel efficacy data at Duchenne adcomm vote
Zachary Brennan
The FDA and Capricor Therapeutics offered sharply opposed interpretations of clinical data backing the company’s potential new cell therapy for the rare and fatal Duchenne …
Ahead of hearing, FDA questions the efficacy of Capricor's Duchenne drug
FDA expert panel recommends against approval of Capricor’s Duchenne drug
Capricor Therapeutics Shares Dive Before Key Review as FDA Panel Challenges Data - Capricor Therapeutics
FDA expert committee reviews Capricor Therapeutics’ Duchenne drug
FDA Committee Votes Down Duchenne Drug
FDA Scientists Raise Questions About Duchenne Drug
Capricor Investigation Notice: Levi & Korsinsky Notifies Investors of Pending Investigation Into Capricor (CAPR)
Pharmalittle: We're reading about FDA views on a Duchenne drug, GSK cost savings, and more
FDA scientists question Capricor data; Legend CEO steps down
Securities Fraud Investigation Into Capricor Therapeutics, Inc. (CAPR) Announced Following Critical FDA Review Ahead of Advisory Committee Meeting – Shareholders Who Lost Money Urged To Contact The Law Offices of Frank R. Cruz
FDA staff say Capricor's deramiocel fails to show clear efficacy for Duchenne, tanking shares 65%+ ahead of this week's adcomm…
Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist…
STAT is live-blogging an FDA meeting on Capricor Therapeutics’ treatment for Duchenne muscular dystrophy, which has been the…
FDA briefing documents question Capricor's deramiocel efficacy in DMD, while the company defends its trial analysis ahead of July…
STAT is live-blogging an FDA meeting on Capricor Therapeutics’ treatment for Duchenne muscular dystrophy, which has been the…
A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.
