Capricor Therapeutics, Inc.·Healthcare

Capricor Therapeutics, Inc. (CAPR) Q1 2026 Earnings Call Transcript

Capricor Therapeutics NASDAQ: CAPR said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku.

Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected to commence soon HOPE-3 Phase 3 trial met its primary endpoint (PUL v2.0; upper limb function) and all Type I error-controlled secondary endpoints GMP 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. and NS Pharma, Inc. seeking rescission of U.S. distribution agreement and preliminary injunction; FDA review and PDUFA date unaffected Cash balance of approximately $279 million expected to support operations into Q4 2027 Eligible for a Priority Review Voucher upon approval; PRV is transferable and monetizable, offering potential non-dilutive capital Conference call and webcast today at 4:30 p.m.

Focused on advanced cell therapies for rare diseases, this biotech firm reported a notable insider sale in its latest SEC filing.

Capricor Therapeutics Inc. (NASDAQ:CAPR) on Thursday filed a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary NS Pharma, Inc., alleging that flaws in the companies' U.S. distribution agreement for experimental Duchenne muscular dystrophy treatment Deramiocel could limit patient access to the therapy.

– Company to Host Conference Call on May 12, 2026, at 4:30 p.m. ET – SAN DIEGO, May 04, 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 that it will release its financial results for the first quarter ended March 31, 2026, after the market close on Tuesday, May 12, 2026.
Capricor Therapeutics, Inc., a clinical-stage biotechnology company, focuses on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of spectrum of diseases and disorders. Its lead candidate, CAP-1002, an allogeneic cardiac-derived cell therapy, which has completed phase III clinical trial for the treatment of patients with late-stage Duchenne muscular dystrophy (DMD); and CAP-1002, which is in Phase II clinical trial for the treatment of cytokine storm associated with SARS-CoV-2. The company also develops CAP-2003 that is in pre-clinical development for the treatment of trauma related injuries and conditions; and two vaccine candidates, which are in development stage for the potential prevention of COVID-19. It collaborates with Lonza Houston, Inc. for the clinical manufacturing of CAP-1002, its cell therapy candidate for the treatment of DMD and other indications. The company was founded in 2005 and is headquartered in San Diego, California.