IJR News — today's news from every side

IJR News — today's news from every side

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📊 Approval moversGordon Liu100%

FDA Extends Capricor Deramiocel BLA Review — Aug 24, 2026Capricor Therapeutics announced that the FDA has extended the PDUFA target action date for its Deramiocel BLA for Duchenne muscular dystrophy from August 22, 2026 to November 22, 2026, following the submission of a BLA amendment with 24-month HOPE-3 open-label data and analyses supporting a refined indication focused on preserving upper limb function. The FDA classified the amendment as a major review and Capricor contends the extended data strengthen the case for addressing a significant unmet medical need in DMD, with HOPE-3 meeting its primary endpoint.