Capricor Therapeutics reports Q1 EPS (53c), consensus (32c)

“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 Marban, Capricor’s CEO. “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 potential commercial launch. In parallel, our StealthX vaccine program is on track for a Phase 1 clinical trial initiation in the third quarter of 2025, led by NIAID under Project NextGen, pending NIAID’s regulatory clearance. Financially, we ended the first quarter with a strong cash position of approximately $145 million, enabling us to continue executing strategically as we approach key value-driving milestones.”