regulatory
confidence high
sentiment positive
materiality 0.85
Capricor initiates rolling BLA submission to FDA for deramiocel in DMD cardiomyopathy
CAPRICOR THERAPEUTICS, INC.
- Rolling submission started Oct 9, 2024; plans to complete by end of 2024.
- BLA seeks full approval for deramiocel to treat all DMD cardiomyopathy patients.
- No approved treatments currently exist for DMD cardiomyopathy.
- Application may be eligible for priority review by FDA.