Advancements Toward Deramiocel Approval
Capricor Therapeutics is on track with their BLA for deramiocel to treat DMD cardiomyopathy, with a smooth FDA path and an upcoming advisory committee meeting seen as a positive step.
Strong Safety and Efficacy Data
Deramiocel has demonstrated a strong safety record with over 700 infusions across 250 patients and significant efficacy in slowing cardiac decline, supported by multiple clinical trials and extensions.
Strategic Appointments and Partnerships
Appointment of Dr. Michael Binks as Chief Medical Officer and active collaboration with NS Pharma for U.S. launch readiness strengthens Capricor's commercial prospects.
Robust Financial Position
Capricor has a cash balance of approximately $145 million, with a runway into 2027 and potential non-dilutive cash infusions totaling over $200 million upon FDA approval.
International Expansion Plans
Capricor is actively negotiating for European distribution with Nippon Shinyaku and planning for international expansion of their HOPE-3 trial.