Capricor Therapeutics

CAPR

Market cap $1.58B

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.

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 is upgraded from 'Hold' to 'Buy' following FDA acceptance of the HOPE-3 clinical study report for Deramiocel in DMD cardiomyopathy. The FDA lifted the Complete Response Letter and set a PDUFA date of August 22, 2026, without requiring new studies, increasing regulatory clarity. Phase 3 HOPE-3 data showed Deramiocel slowed disease progression by 54% [PUL] and 91% [LVEF], with additional functional and fibrosis benefits.

Capricor posted a quarterly loss of 62 cents per share, missing the consensus estimate of a 54-cent loss and worsening from a 16-cent loss in the prior-year period.

Capricor Therapeutics, Inc. (CAPR) Q4 2025 Earnings Call Transcript

SAN DIEGO, March 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 fourth quarter and full year ended December 31, 2025, and provided a corporate update.

SAN DIEGO, March 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 additional analyses and new functional outcomes data from the Phase 3 HOPE-3 clinical trial of Deramiocel in Duchenne muscular dystrophy (DMD), which were presented yesterday at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.