Capricor Therapeutics, Inc.

Capricor Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics, primarily focusing on redefining the treatment landscape for rare diseases. The company emphasizes a patient-focused approach and precision medicine, with its corporate and research headquarters located in San Diego, California.

At the forefront of Capricor's pipeline is Deramiocel (formerly CAP-1002), an allogeneic cardiac-derived cell therapy currently in late-stage (Phase 3) clinical development for the treatment of Duchenne muscular dystrophy (DMD). Beyond cell therapy, Capricor is also leveraging its proprietary exosome technology, known as the StealthX™ platform. This platform is designed for vaccinology and the targeted delivery of various therapeutic molecules, including oligonucleotides, proteins, and small molecules, with the potential to address a broad spectrum of diseases.

Recent notable developments include the FDA lifting its Complete Response Letter and resuming the review of the Deramiocel Biologics License Application (BLA) as a Class 2 resubmission, with a PDUFA target action date set for August 22, 2026. This follows positive HOPE-3 Phase 3 results demonstrating significant functional benefits for Deramiocel in Duchenne muscular dystrophy. Dr. Linda Marbán serves as the Chief Executive Officer, a role she has held since November 2013, leading the company's strategic direction in the biotechnology sector.