"We continue to make strong progress in 2025 as we advance toward our goal of delivering the first approved therapy for Duchenne cardiomyopathy—a condition with no approved treatments," said Linda Marbán, Ph.D., Capricor's Chief Executive Officer. "We continue to have active dialogue with the FDA as they review our BLA and we remain on track with our PDUFA target action date of August 31, 2025. Preparations are progressing for our upcoming FDA advisory committee meeting, pre-approval inspection, and potenti ...