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NUVL PDUFA Date: Zidesamtinib (NVL-520)

FDA decision (PDUFA) target 2026-09-18 · Nuvalent Inc. · ROS1 Non-small cell lung cancer (NSCLC)

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

$123.45$88.49
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-18
Drug / candidateZidesamtinib (NVL-520)
IndicationROS1 Non-small cell lung cancer (NSCLC)
CompanyNuvalent Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT05118789 · recruiting

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FAQ

When is the NUVL PDUFA date?
The FDA PDUFA target date for NUVL (Nuvalent Inc.) is 2026-09-18 for Zidesamtinib (NVL-520). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is NUVL's drug Zidesamtinib (NVL-520)?
Zidesamtinib (NVL-520) is Nuvalent Inc.'s candidate under FDA review for ROS1 Non-small cell lung cancer (NSCLC).
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.