Capricor Therapeutics IncFDA advisory committee voted against cardiomyopathy question and FDA extended review, delaying approval.

Capricor Therapeutics announced plans to amend its Biologics License Application for Deramiocel after an FDA advisory committee voted 3 to 9 against the cardiomyopathy question, with the PDUFA target action date set for August 22. CEO Linda Marbán said the company will submit an amendment including 24-month open-label extension data from the HOPE-3 study and additional analyses, and the FDA has indicated willingness to review it and extend the action date upon receipt. The company also disclosed a statistical model change that shifted the LVEF endpoint from a 2.4 percentage point treatment difference with a p-value of 0.04 to a 1.8 percentage point difference with a p-value of 0.09, while the primary skeletal function endpoint remained statistically significant. Capricor reported cash and marketable securities of approximately $237.9 million as of June 30, 2026, a net loss of $40.7 million or $0.70 per share for the second quarter, and said all non-Deramiocel pipeline work is on hold pending regulatory clarity.
Capricor Therapeutics IncFDA advisory committee voted against cardiomyopathy question and FDA extended review, delaying approval.