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Capricor Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected to commence soonHOPE-3 Phase 3 trial met its primary endpoint (PUL v2.0; upper limb function) and all Type I error-controlled secondary endpointsGMP manufacturing facility fully operational; second-floor expansion well underway Chief Commercial Officer with direct DMD commercial experience expected to join the Company in the coming weeks Filed suit against Nippon Shinyaku Co., Ltd.
About this update from Capricor Therapeutics, Inc.
SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced its financial results for the first quarter ended March 31, 2026, and provided a corporate update. "Capricor enters this pivotal moment with important regulatory and clinical momentum as we work toward potential approval of Deramiocel for the treatment of Duchenne muscular dystrophy," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "With the FDA review of our BLA underway and a PDUFA target action date of August 22, 2026, our highest priority is execution: working closely with the Agency, preparing for potential launch, and continuing to build the capabilities of a commercial-stage company. We remain focused on ensuring that Deramiocel reaches every eligible patient as quickly as possible, which is why we took necessary legal action against NS Pharma to remove a structural barrier to patient access created by a flawed pricing arrangement and to address our distributor's failure to fulfill its commercial obligations." “Our thesis is straightforward: a potential first-in-class approval in a defined rare disease population, proprietary in-house manufacturing, a growing pipeline, and a leadership team with the conviction and the capital to execute,” said Dr. Marbán. “We are building something that will create meaningful and durable value for patients, for this company, and for the shareholders who have believed in this mission.” First Quarter 2026 and Recent Highlights First Quarter 2026 Financial Results Upcoming Events Conference Call and Webcast To participate in the conference call, please dial 1-800-717-1738 (Domestic) or 1-646-307-1865 (International) and reference the conference ID: 60968. Participants may dial in using the numbers above and ask to be joined to the call or click the Call Me™ link for instant telephone access to the event. To participate via a webcast, please click here. A replay of the webcast will be available shortly after the conclusion of the live event and will be accessible in the Investors section of the Company’s website. About Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneratio...
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