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FDA extends Deramiocel review to assess new HOPE-3 data; Capricor seeks an indication focused on upper limb function.
Deramiocel manufacturing buildout raises spending before approval as cardiac setbacks threaten launch timing and indication scope.
Nonbinding FDA panel vote opposed Deramiocel’s DMD cardiomyopathy efficacy evidence; Capricor is working with FDA on a path forward.
FDA panel finds Deramiocel evidence insufficient for DMD cardiomyopathy, a narrower indication than proposed; vote is non-binding
HOPE-3 model update leaves Deramiocel’s LVEF result no longer statistically significant; primary efficacy endpoint is unchanged.
New San Diego headquarters and manufacturing lease ties cleanroom and lab expansion to FDA approval of Deramiocel.
Coverage: 10-K, 10-Q and 8-K filings filed since Jul 1, 2026.
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