Capricor Outlines Daramyocell’s FDA Review and Launch Prep as Distributor Dispute Looms

Overview

• Capricor said the FDA set August 22, 2026 as the target decision date, known as the PDUFA date, for Daramyocell’s license application.
• On its quarterly call, the company said it is building a commercial team and starting payer outreach to prepare for a potential launch.
• Capricor is expanding manufacturing from an estimated output of about 250 doses a year and is seeking an interim cold‑storage label to support early supply.
• The company filed legal action against NS Pharma and Nippon Shinyaku over proposed distribution terms it says would hinder patient access through pricing.
• CEO Linda Marban said any repayment tied to the dispute would likely match the $50 million previously received, while Capricor reported about $279 million in cash and higher spending for regulatory and production needs.