U.S. sales partnership for CAP-1002 and preparation for a Phase 3 trial
First written in FY2022-Q3. 6 of 13 entries say "Advanced", first in FY2023-Q1. Latest entry: 2026-11-13.
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- 2026-11-13SoftenedRevision to earnings forecast
「FDAにより、重要な申請内容の変更（Major Amendment）として受理された結果、PDUFA dateは2026年11月22日に延長されました。」
CAP-1002の審査終了目標日が2026年8月22日から11月22日に延長され、発売時期の不確実性が継続している。 - FY2026AdvancedAnnual report
「The company announced positive topline data from the Phase 3 HOPE-3 trial in December 2025. The company submitted the Phase 3 trial data and related materials to the FDA and completed its response to the CRL, prompting the FDA to resume its review. The PDUFA date was set for 22 August 2026.」
Following the CRL, CAP-1002 progressed through the announcement of positive topline data from the Phase 3 trial, submission of materials to the FDA, resumption of the review and setting of the PDUFA date for 22 August 2026. - 2026-05-15AdvancedRevision to earnings forecast
「同社はFDAに第三相試験のデータおよび関連資料を提出し、CRLに対する対応を完了したことから、FDAによる審査が再開されました。審査終了目標日（PDUFA date）は2026年8月22日に設定されました。」
CAP-1002について、CRL後の対応完了によりFDA審査が再開され、審査終了目標日が設定された。 - FY2026-H1Receipt of a Complete Response Letter regarding the marketing authorisation applicationAnnual report
「CAP-1002 (generic name: deramiocel), a treatment for Duchenne muscular dystrophy, has been undergoing a Phase 3 trial in the United States since July 2022. Capricor Therapeutics completed a rolling marketing authorisation application for Duchenne muscular dystrophy-associated cardiomyopathy in December 2024, but in July 2025 received a Complete Response Letter from the FDA stating that approval could not be granted based on the submitted data.」
CAP-1002 remains in a Phase 3 trial in the United States, but following completion of the rolling marketing authorisation application for the cardiomyopathy indication, the Company received a Complete Response Letter from the FDA in July 2025. - FY2025AdvancedAnnual report
「CAP-1002 (generic name: deramiocel), a treatment for Duchenne muscular dystrophy, has been undergoing a Phase 3 trial in the United States since July 2022. In December 2024, Capricor Therapeutics completed a rolling marketing authorisation application for Duchenne muscular dystrophy-associated cardiomyopathy.」
In addition to the ongoing Phase 3 trial in the United States, CAP-1002 completed the rolling marketing authorisation application process for Duchenne muscular dystrophy-associated cardiomyopathy in December 2024. - FY2025-H1AdvancedAnnual report
「CAP-1002 (generic name: deramiocel), a treatment for Duchenne muscular dystrophy, entered into a sales partnership agreement in the United States with Capricor Therapeutics (U.S.) in January 2022. Capricor Therapeutics has been conducting a Phase 3 trial in the United States since July 2022. Capricor Therapeutics began a rolling marketing authorisation application in October 2024 for Duchenne muscular dystrophy-associated cardiomyopathy.」
In addition to the ongoing Phase 3 trial in the United States, CAP-1002 entered the rolling marketing authorisation application process for Duchenne muscular dystrophy-associated cardiomyopathy in October 2024. - FY2024-Q3RestatedAnnual report
「CAP-1002, a treatment for Duchenne muscular dystrophy, entered into a sales partnership agreement in the United States with Capricor Therapeutics (U.S.) in January 2022. Capricor Therapeutics has been conducting a Phase 3 trial in the United States since July 2022.」
Following the execution of the U.S. sales partnership agreement for CAP-1002, the Phase 3 trial in the United States that began in July 2022 remains under way. - FY2024-Q2RestatedAnnual report
「CAP-1002, a treatment for Duchenne muscular dystrophy, entered into a sales partnership agreement in the United States with Capricor Therapeutics (U.S.) in January 2022. Capricor Therapeutics has been conducting a Phase 3 trial in the United States since July 2022.」
Following the execution of the U.S. sales partnership agreement for CAP-1002, the Phase 3 trial in the United States that began in July 2022 remains under way. - FY2024-Q1RestatedAnnual report
「CAP-1002, a treatment for Duchenne muscular dystrophy, entered into a sales partnership agreement in the United States with Capricor Therapeutics (U.S.) in January 2022. Capricor Therapeutics has been conducting a Phase 3 trial in the United States since July 2022.」
Following the execution of the U.S. sales partnership agreement for CAP-1002, the Phase 3 trial in the United States that began in July 2022 remains under way. - FY2023AdvancedAnnual report
「Exclusive sales partnership agreement in Japan for CAP-1002 (treatment for Duchenne muscular dystrophy) 2023.2 Renewed annually thereafter, beginning one year after the end of the re-examination period or on the later of the patent expiry dates」
In addition to the existing U.S. sales partnership, the Company entered into an exclusive sales partnership agreement in Japan for CAP-1002 in February 2023. - FY2023-Q2RestatedAnnual report
「• For CAP-1002, a treatment for Duchenne muscular dystrophy, the company signed a sales partnership agreement in the United States with Capricor Therapeutics (United States) in January 2022. Capricor Therapeutics has been conducting a Phase 3 trial in the United States since July 2022.」
Following the execution of the U.S. sales partnership agreement for CAP-1002 in January 2022, the Phase 3 trial in the United States initiated in July of that year remains under way. - FY2023-Q1AdvancedAnnual report
「CAP-1002, a treatment for Duchenne muscular dystrophy, entered into a sales partnership agreement in the United States with Capricor Therapeutics (U.S.) in January 2022. Capricor Therapeutics initiated a Phase 3 trial in the United States in July 2022.」
Following the execution of the U.S. sales partnership agreement for CAP-1002, the licensee initiated a Phase 3 trial in the United States in July 2022. - FY2022-Q3First statedAnnual report
「CAP-1002, a treatment for Duchenne muscular dystrophy, entered into a sales partnership agreement in the United States with Capricor Therapeutics (U.S.) in January 2022. Capricor Therapeutics is preparing a Phase 3 trial in the United States.」
The Company stated for the first time that it had entered into a U.S. sales partnership agreement for CAP-1002 with Capricor Therapeutics and that the latter was preparing a Phase 3 trial in the United States.