Capricor Cuts 10% of Staff and Shelves Side Programs Ahead of Its Nov. 22 FDA Decision
- Capricor reduced its workforce by about 10% (roughly 23 people) and slowed work outside deramiocel, including its exosome platform.
- The FDA's target action date for the Duchenne cell therapy is November 22; an advisory committee earlier voted 9-3 against approval for the cardiomyopathy claim.
- The company has since narrowed its request to upper-limb function, where Phase 3 HOPE-3 met its primary endpoint, and is raising commercial manufacturing spend.
💡 Points Based on public reports
The company is concentrating every resource on one binary outcome while its activist shareholder pushes for capital preservation. The narrowed upper-limb request fits the HOPE-3 win, but the cardiac endpoint missed significance overall, so the label wording matters as much as approval itself. A rejection would leave a thin, one-asset company with few fallbacks.
📰 Source · BioSpace ↗ Capricor parts ways with 10% of staff as FDA decision on DMD cell therapy nears