News for Nippon Shinyaku Co., Ltd. (4516.T)

- Webinar to be held on Tuesday, July 29, 2025, at 1:00 p.m. ET -

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophyFDA advised Capricor to request a meeting to determine next steps toward potential approvalConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the Company’s lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval

Four-year data show preservation of cardiac function, including LVEFSkeletal muscle disease progression continues to slow with extended treatment (PUL v2.0)Dera

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U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor's focus in neuromuscular diseasesCapri

PR NewswirePARAMUS, N.J., May 14, 2025 PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (

Biologics License Application (BLA) for deramiocel in the treatment of Duchenne muscular dystrophy (DMD) remains under priority review by the U.S. FDA, with a t

Company to Host Conference Call, May 13, 2025 at 4:30 p.m. ET SAN DIEGO, May 06, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics ( CAPR), a biotechnology com

-Company remains on track for PDUFA target action date of August 31, 2025- -Advisory committee meeting to be held in advance of target action date-

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Announced the U.S. FDA has accepted our Biologics License Application (BLA) seeking full approval of deramiocel for the treatment of Duchenne muscular dystrophy

--Preservation of Skeletal Muscle Function Shown Over 3 Years Resulting in 52% Slowing of Disease-- --Data Presented at the 2025 Muscular Dystrophy Ass

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Company to Host Conference Call, March 19, 2025 at 4:30 p.m. ET SAN DIEGO, March 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics ( CAPR), a biotechnology

PR NewswirePARAMUS, N.J., March 10, 2025 PARAMUS, N.J., March 10, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Lt

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