Orca BLA closer to milestone approval

7 October 2025

Privately-held cell therapy company Orca Bio has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking approval for Orca-T.

The Californian company is seeking approval for its lead investigational allogeneic T-cell immunotherapy to treat hematological malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS).

Orca’s BLA review has been given a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

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