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Indication
AML, ALL, MDS — allogeneic cell therapy for hematologic malignancies
Key Notes
FDA extended BLA review on April 1, 2026 — new PDUFA target action date is July 6, 2026 (extension from April 6, 2026). Extension was requested to allow FDA additional time to review updated Chemistry, Manufacturing, and Controls (CMC) data submitted by Orca Bio. Investigational allogeneic T-cell therapy for AML, ALL, and MDS. Phase 3 Precision-T trial showed significantly higher cGVHD-free survival vs standard allo-HSCT. First-in-class high-precision cell therapy.
⚠️ Not Investment Advice: This information is provided for educational purposes only.
PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on
historical base rates and do not account for drug-specific factors. Always consult a financial advisor
before making investment decisions.
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