Capricor Soars After Cantor Upgrade as FDA Path for Deramiocel Becomes Clearer
Analyst upgrade sends Capricor shares higher after company outlines BLA amendment path for deramiocel focused on upper-limb function.
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FDA Panel Backs Replimune’s Melanoma Drug After Multiple Rejections
FDA panel votes 10-3 for Replimune’s RP1 melanoma drug after two rejections, citing benefits for resistant patients despite messy data.
FDA Panel Votes 9-3 Against Capricor’s Duchenne Heart Therapy Over Weak Evidence
Final decision due Aug. 22.
Capricor Shares Plunge After FDA Briefing Documents Raise Doubts on Deramiocel
FDA briefing documents for Capricor’s deramiocel question effectiveness and highlight safety risks ahead of the July 29 advisory committee.
Capricor Shares Fall as FDA Schedules Advisory Committee for Deramiocel
Capricor Therapeutics stock fell after the Food and Drug Administration set a July 29 review of its DMD therapy; a decision is due Aug. 22.
FDA Lifts Rejection and Schedules August 2026 Review for Deramiocel
Capricor Therapeutics receives new PDUFA target date of August 22, 2026 for Deramiocel BLA. Potential first therapy to treat both heart and skeletal muscle damage in Duchenne muscular dystrophy (DMD).