FDA Panel Votes Against Capricor's Duchenne Drug Deramiocel
Story updated Rewritten when the story materially grows; the wire is checked every 15 minutesAbout this data
An FDA expert panel has recommended against the approval of Capricor Therapeutics' treatment for Duchenne muscular dystrophy. The decision follows a contentious regulatory review process that has raised significant concerns among stakeholders.
The panel's vote marks a setback for Capricor, which has been seeking approval for its cell therapy aimed at treating Duchenne cardiomyopathy, a serious complication associated with the disease. The outcome of this meeting could have far-reaching implications for the company's future and for patients seeking new treatment options.
Sources
Every quote below is verbatim from the article it is attributed to.
“At a contentious meeting with possible implications”
biopharma dive — Capricor Duchenne cell therapy voted down by FDA panel“STAT is live-blogging an FDA meeting on Capricor Therapeutics’ treatment for Duchenne muscular dystrophy, which has been the subject of a contentious regulatory review.”
stat news — STAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drug