HOPE-3 Phase 3 Clinical Study
The upcoming top-line readout from the HOPE-3 Phase 3 clinical study of Daramycin, aimed at treating Duchenne muscular dystrophy, represents a significant milestone. The trial is one of the largest double-blind, placebo-controlled studies in the Duchenne population, enrolling 105 participants across 20 centers in the US.
Strong Safety Profile
Daramycin has demonstrated a strong and consistent safety profile across more than 800 infusions for approximately 150 boys and young men with Duchenne, with no new or emerging safety signals observed.
CMC Achievements
The San Diego commercial facility is fully operational and preparing for GMP production, with all CMC-related items cited in the CRL addressed. This ensures readiness for commercialization and long-term product consistency.
Potential Approval and Non-dilutive Capital Opportunities
If Daramycin is approved, Capricor is eligible for an $80 million milestone payment from NS Pharma and a priority review voucher.
Exosome Platform Development
The StealthX program under Project NextGen is advancing, with a Phase 1 clinical trial evaluating a next-generation COVID-19 vaccine. Positive results could lead to strategic collaborations and highlight the platform's potential.