regulatory
confidence high
sentiment positive
materiality 0.85
Capricor files BLA for deramiocel in DMD cardiomyopathy; reports ~$85M cash as of Sept 30
CAPRICOR THERAPEUTICS, INC.
- BLA for deramiocel filed Oct 2024 seeking full approval for DMD cardiomyopathy; full submission by year-end 2024.
- HOPE-2/OLE data vs natural history supports BLA; HOPE-3 Cohorts A+B combined as post-approval study, Cohort A unblinding paused.
- StealthX SARS-CoV-2 vaccine selected for Project NextGen; manufacturing ongoing, delivery to NIAID by end-2024.
- Private placement to Nippon Shinyaku: 2.8M shares at $5.36 for ~$15M; ATM sales: 5.5M shares at $9.84 avg for ~$53.9M.
- Preliminary cash balance ~$85M as of Sept 30, 2024.