Ivan Hosinov's questions to Capricor Therapeutics Inc (CAPR) leadership • Q2 2025
Question
An analyst from Vladimir Pharma asked for clarification on the BLA review timeline post-resubmission, the rationale for selecting LVEF as the primary endpoint, and the implications of recent events for the Becker Muscular Dystrophy (BMD) program.
Answer
CEO Linda Marbán explained that the review timeline is a key topic for the FDA meeting. She justified the LVEF endpoint by citing recent studies that established its link to clinical outcomes in DMD, making it a relevant primary endpoint. She stated that plans for the BMD program are paused until there is clarity on the path forward for deromyocel in DMD.