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Orca Bios BLA for Hematologic Malignancy Cell Therapy Orca-T Accepted by FDA With Priority Review October 7, 2025 Orca Bios BLA for Orca-T, an investigational allogeneic cell therapy product intended to treat various hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndromes (MDS), has been accepted by the FDA with priority review

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These delivery constraints likely contribute to the heterogeneous efficacy signals reported with empiric biologics and underscore the need for protocols that explicitly address localization, sequencing, and persistence of therapy