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Orca-T

Orca Bio

Priority Review Breakthrough Therapy BLA

PDUFA Date

April 6, 2026

Time Remaining

13 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical BLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

AML, ALL, MDS — allogeneic cell therapy for hematologic malignancies

Key Notes

Investigational allogeneic T-cell therapy. First-in-class for blood cancers post-transplant.

⚠️ 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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