Back to today’s briefing

Story perspectives

Capricor Optimistic on CAP-1002 FDA Approval After Meeting

9/26/2025

50 9

Summary

Story summary

Capricor Therapeutics and U.S. Food and Drug Administration (FDA) clarified path to CAP-1002 (deramiocel) approval for Duchenne after a meeting.
The FDA previously rejected Capricor's July submission over efficacy concerns.
Capricor CEO Linda Marbán expressed optimism FDA will reconsider Hope-3 data.
Hope-3 enrolled 105 patients, focusing on upper limb function and cardiac performance; manufacturing issues resolved, shares up approximately 9%.

1 of 1

Story summary

Capricor Therapeutics and U.S. Food and Drug Administration (FDA) clarified path to CAP-1002 (deramiocel) approval for Duchenne after a meeting.
The FDA previously rejected Capricor's July submission over efficacy concerns.
Capricor CEO Linda Marbán expressed optimism FDA will reconsider Hope-3 data.
Hope-3 enrolled 105 patients, focusing on upper limb function and cardiac performance; manufacturing issues resolved, shares up approximately 9%.