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SMMT PDUFA Date: Ivonescimab plus platinum-doublet chemotherapy

FDA decision (PDUFA) target 2026-11-14 · Summit Therapeutics Inc. · EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
More Cancer & Oncology FDA decisions →All November 2026 PDUFA dates →

The story

Ivonescimab plus platinum-doublet chemotherapy is under FDA review to treat EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Balance sheet: about 19 months of cash, runway ~19 mo (estimated).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapBTAI . 2026-11-14Same month decision . IGALMI® (dexmedetomidine)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

SMMT run-up into the PDUFA (last ~120 days)

$26.38$13.05
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-11-14
Drug / candidateIvonescimab plus platinum-doublet chemotherapy
IndicationEGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
CompanySummit Therapeutics Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT06396065

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FAQ

When is the SMMT PDUFA date?
The FDA PDUFA target date for SMMT (Summit Therapeutics Inc.) is 2026-11-14 for Ivonescimab plus platinum-doublet chemotherapy. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is SMMT's drug Ivonescimab plus platinum-doublet chemotherapy?
Ivonescimab plus platinum-doublet chemotherapy is Summit Therapeutics Inc.'s candidate under FDA review for EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.