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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)
More Cancer & Oncology FDA decisions →All September 2026 PDUFA dates →

The story

Zidesamtinib (NVL-520) is under FDA review to treat ROS1 Non-small cell lung cancer (NSCLC). Balance sheet: about 49 months of cash, runway into 2029 (company-guided).
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 . TruqapTLX . 2026-09-11Same month decision . TLX101-Px
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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
See the full 2026 PDUFA calendar →

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% (763-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · mid-cap cohortn=222 · median -0.0% · 49% up
under -30%: 5 of 222 (2%)<-30-30 to -15%: 6 of 222 (3%)-15 to -7%: 7 of 222 (3%)-7 to -3%: 21 of 222 (9%)-3 to +3%: 134 of 222 (60%)±3+3 to +7%: 34 of 222 (15%)+7 to +15%: 9 of 222 (4%)+15 to +30%: 1 of 222 (0%)over +30%: 5 of 222 (2%)>+30
Distribution of next-day % moves after the FDA decision for mid-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.