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omilancor

Landos Biopharma / Ji Xing
Standard Review Fast Track NDA
PDUFA Date
August 20, 2026
Time Remaining
129 days
Review Type
Standard (10 mo)
85%
Baseline PoA
NDA standard review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
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Indication

Ulcerative colitis (UC)

Key Notes

Oral LANCL2 agonist. Phase 3 data demonstrated remission in moderate-to-severe UC.
⚠️ 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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