Capricor Therapeutics (CAPR, Financial) is progressing significantly towards its objective of delivering the first approved treatment for Duchenne cardiomyopathy, a condition that currently lacks approved therapies. The company is actively engaging with the FDA as it evaluates their Biologics License Application (BLA), with a target action date set for August 31, 2025, under the Prescription Drug User Fee Act (PDUFA). Preparations are underway for forthcoming FDA advisory committee meetings, pre-approval inspections, and the anticipated commercial launch.
Simultaneously, Capricor's StealthX vaccine program is poised to begin Phase 1 clinical trials in the third quarter of 2025. This initiative is spearheaded by the National Institute of Allergy and Infectious Diseases (NIAID) as part of Project NextGen, pending regulatory approval from NIAID. Financially, Capricor concluded the first quarter of the year with a robust cash reserve of approximately $145 million, positioning the company well to continue its strategic initiatives as it approaches key milestones.
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