Capricor Therapeutics reports Q2 EPS (57c), consensus (48c)

Cash, cash equivalents and marketable securities totaled approximately $122.8M as of June 30. The company says its cash position is expected to support planned operations into the fourth quarter of 2026. Capricor has a Type A meeting with the FDA scheduled to discuss the Deramiocel Biologics License Application and path toward potential approval following the receipt of a complete response letter. The company seeks to resubmit its BLA based on its existing dataset, with HOPE-3 data, expected in Q4 2025, potentially serving as supportive and confirmatory evidence. “We remain steadfast in our mission to deliver the first approved therapy for Duchenne cardiomyopathy-a serious and progressive complication of DMD with no approved treatments,” said Linda Marban, Ph.D., CEO of Capricor. “While the receipt of a CRL was a setback, we are working diligently to define a clear regulatory path forward, which has been delineated in our Type A briefing document. Our objective remains to gain approval based on our current Biologics License Application submission as expeditiously as possible, with the primary evidence being the totality of data from our HOPE-2 trial and its open-label extension. These results provide a compelling foundation for our submission, and we are fully prepared to supplement the BLA with HOPE-3 data as needed, with topline results expected in the fourth quarter of 2025.”