Capricor Therapeutics Completes Type-B Meeting With FDA For CAP-1002 Program For Duchenne Muscular Dystrophy With Aim To Expedite BLA Pathway
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Capricor Therapeutics has completed a Type-B meeting with the FDA for its CAP-1002 program aimed at treating Duchenne Muscular Dystrophy. The FDA has granted a pre-BLA meeting request and a rolling BLA submission after reviewing the 3-year results of the HOPE-2 and HOPE-2 OLE studies.
June 11, 2024 | 1:31 pm
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Capricor Therapeutics has completed a Type-B meeting with the FDA for its CAP-1002 program aimed at treating Duchenne Muscular Dystrophy. The FDA has granted a pre-BLA meeting request and a rolling BLA submission after reviewing the 3-year results of the HOPE-2 and HOPE-2 OLE studies.
The completion of a Type-B meeting with the FDA and the granting of a pre-BLA meeting request and rolling BLA submission are significant regulatory milestones. These developments indicate progress in the approval process for CAP-1002, which could positively impact Capricor Therapeutics' stock price in the short term.
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