Who Owns Capricor Therapeutics Inc (CAPR)? 13F Institutional Holders (Q2 2026)

On August 24, 2026, Capricor Therapeutics (CAPR) announced that the FDA has extended the review deadline for its biologics license application for Deramiocel, an experimental cell therapy for Duchenne muscular dystrophy, pushing the target action date from August 22 to November 22, 2026 — a three-month delay. The extension came about because the FDA classified the submission as a major amendment after Capricor added 24-month open-label extension data from its pivotal Phase 3 HOPE-3 study. Alongside the new data, the company also asked the FDA to weigh existing and updated evidence in support of a refined proposed indication focused on upper limb function, which was HOPE-3's primary endpoint.

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Capricor Therapeutics disclosed that on July 29, 2026, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted 9 to 3 (with no abstentions) that available evidence did not support the effectiveness of Deramiocel for treating cardiomyopathy in patients with Duchenne muscular dystrophy. The vote is non-binding, and the FDA’s PDUFA target action date for Capricor’s Biologics License Application remains August 22, 2026. The company issued a press release on July 30 to announce the outcome.

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Capricor Therapeutics signed a lease for a new 171,000-square-foot headquarters in San Diego, including expanded manufacturing cleanrooms, R&D labs, and offices. The initial monthly rent is about $958,000 with 3% annual increases, but the company receives an 18-month full rent abatement and a six-month partial abatement. The lease term begins when an FDA approval condition for Deramiocel is met or by Dec 31, 2026, whichever comes first, and rent starts 12 months later. If FDA approval does not occur by year-end, either party can terminate the lease.

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