On July 29, 2026, the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted that available evidence did not support the effectiveness of Deramiocel for treating cardiomyopathy in patients with Duchenne muscular dystrophy (DMD), with a vote of 3 for and 9 against. The recommendation is non-binding, and the FDA will consider it alongside the complete administrative record during its ongoing review of the Biologics License Application. The PDUFA target action date remains August 22, 2026. While the committee was directionally supportive regarding upper limb function data from the Phase 3 HOPE-3 trial, this negative vote on cardiac efficacy represents a significant regulatory setback for the company's lead asset. Capricor Therapeutics is a biotechnology company developing cell and exosome-based therapeutics for rare diseases.

Capricor Therapeutics announced the publication of final one-year results from its Phase 3 HOPE-3 trial for Deramiocel in Duchenne muscular dystrophy in The Lancet, confirming the primary endpoint with a 54% slowing of upper limb function decline (p=0.03). However, an updated statistical model for the key secondary cardiac endpoint, left ventricular ejection fraction, yielded a p-value of 0.09 compared to the previously reported 0.04. Concurrently, the FDA issued a Form 483 following a Bioresearch Monitoring inspection citing documentation and vendor oversight issues, though management asserts data integrity remains intact. The company maintains its PDUFA target action date for Deramiocel of August 22, 2026. Capricor Therapeutics is a biotechnology company developing cell and exosome-based therapeutics for rare diseases.

Capricor Therapeutics, Inc. entered into a lease agreement for approximately 171,000 rentable square feet in San Diego, California, to serve as its new headquarters and expanded manufacturing cleanrooms, R&D laboratory, and administrative offices. The lease term commences on the earlier of FDA approval of Deramiocel for Duchenne muscular dystrophy or December 31, 2026, with an initial monthly base rent of approximately $958,000, subject to a 3.0% annual increase. Capricor will receive an 18-month full rent abatement and a subsequent 06-month partial rent abatement. Capricor Therapeutics, Inc. is a biotechnology company focused on developing therapeutic solutions for neuromuscular and neuromuscular-related diseases.

Capricor Therapeutics, Inc. announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee is scheduled to convene on July 29, 2026, to discuss the company's Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD). The company's BLA remains on track for a PDUFA action date of August 22, 2026. Capricor Therapeutics, Inc. is a biotechnology company focused on developing cell and gene therapies for neuromuscular and neuromuscular-related diseases.

Capricor Therapeutics, Inc. held its Annual Meeting of stockholders on June 4, 2026, and announced the election of eight directors to the Company's Board of Directors. The meeting also included votes on the ratification of its independent accounting firm, the approval ofing of executive officer compensation, and the eration of an amendment to the Certificate of Incorporation regarding officer exculpation.