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"https://www.capricor.com/investors/news-events/press-releases/detail/354/capricor-therapeutics-announces-extension-of-pdufa-target", "stream_id": null, "stream_ids": [ "17827952984215536", "17855502022064890" ], "summary": "Capricor Therapeutics has received a three-month extension from the FDA for the PDUFA target action date regarding its Biologics License Application (BLA) for Deramiocel, moving the date from August 22, 2026, to November 22, 2026. This extension follows the submission of a major amendment by Capricor, which includes 24-month open-label extension data from the pivotal Phase 3 HOPE-3 study. The company is seeking a refined indication focused on upper limb function, which was the primary endpoint of the HOPE-3 trial.", "tags": [ "Capricor Therapeutics", "FDA Approval", "Linda Marb\u00e1n" ] } ], "stories_per_domain": 24, "story_attempt": 1, "story_slot": 24, "story_units": [ { "paragraphs": [ { "citations": [ { "claim_id": "1787604738144739938", "kind": "claim", "manifest_id": "1787604044543130285" }, { "claim_id": "1787604738161448623", "kind": "claim", "manifest_id": "1787604044543130285" } ], "text": "The FDA pushed back its decision deadline for Capricor Therapeutics' application for Deramiocel, moving the target action date from August 22, 2026, to November 22, 2026. This three-month delay gives the agency time to review new clinical data, shifting the timeline for a potential commercial launch of a therapy aimed at a rare genetic disease." }, { "citations": [ { "claim_id": "1787604738151769286", "kind": "claim", "manifest_id": "1787604044543130285" }, { "claim_id": "1787604738153842174", "kind": "claim", "manifest_id": "1787604044543130285" } ], "text": "The delay happened because Capricor submitted a major amendment to its application. This submission includes 24-month open-label extension data from its Phase 3 HOPE-3 study. 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