Capricor Therapeutics is a clinical-stage biotech focused entirely on Deramiocel, a cell therapy for Duchenne muscular dystrophy (DMD). DMD is a rare, fatal genetic disease affecting roughly 15,000 boys and young men in the U.S., progressively destroying skeletal and cardiac muscle. Deramiocel is derived from cardiosphere-derived cells (CDCs) isolated from donated human hearts, administered intravenously every three months. The cells release signaling factors that suppress inflammation and fibrosis in muscle tissue, slowing disease progression in both skeletal and cardiac muscle. This mechanism is distinct from approved exon-skipping and gene therapies, which target the underlying genetic mutation rather than downstream inflammatory damage, and no approved therapy currently addresses DMD-associated cardiomyopathy. Capricor filed a BLA with the FDA in late 2024; after receiving a Complete Response Letter, Capricor resubmitted using Phase 3 HOPE-3 trial data, and the FDA set a new PDUFA date of August 22, 2026. If approved, Capricor manufactures Deramiocel at its San Diego facility and sells it to Nippon Shinyaku, which distributes in the U.S., with Capricor receiving a 30%-50% revenue share on net sales. Nippon Shinyaku also owes Capricor an $80M milestone upon U.S. approval, plus up to $605M in sales-based milestones. Capricor's current San Diego facility supports roughly 250 patients per year, with an expansion underway targeting roughly 2,500 patients annually by late 2027. Capricor also has an early-stage exosome delivery platform, StealthX, but this is not a near-term commercial driver.