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ivonescimab

Summit Therapeutics · $SMMT
Standard Review Fast Track BLA
PDUFA Date
November 14, 2026
Time Remaining
129 days
Review Type
Standard (10 mo)
80%
Baseline PoA
BLA standard review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NGM

Updated just now · Data: FMP
Current Price
$15.69 -31.75%
$-7.30 today
Day: $15.39 – $15.88
Market Cap
N/A
52-Week Range
$12.55
$30.98
Current price is at 17% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

EGFR-mutated advanced non-squamous NSCLC after progression on a 3rd-gen EGFR TKI (with chemotherapy)

Key Notes

FDA accepted the BLA for ivonescimab plus platinum-doublet chemotherapy with a PDUFA goal date of November 14, 2026. First-in-class PD-1 by VEGF bispecific antibody. BLA based on the Phase 3 HARMONi trial (ivonescimab plus chemo vs placebo plus chemo in EGFRm NSCLC post-TKI). Partnered with Akeso. Source: Summit 8-K and press release (BLA acceptance, January 2026).
⚠️ 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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