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Home › PDUFA Calendar › NUVL

NUVL PDUFA Date: Zidesamtinib (NVL-520)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on July 22, 2026, 58 days before its September 18, 2026 goal date. Decision page with the source and measured reaction.
FDA decision Approved July 22, 2026 · Nuvalent Inc. · ROS1 Non-small cell lung cancer (NSCLC)
More Cancer & Oncology FDA decisions →All September 2026 PDUFA dates →

The story

Zidesamtinib (NVL-520) was approved by the FDA on July 22, 2026 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 decisionApproved July 22, 2026
FDA goal 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

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on NUVL's Zidesamtinib (NVL-520)?
The FDA decided NUVL's (Nuvalent Inc.) application for Zidesamtinib (NVL-520) on July 22, 2026: Approved. The FDA goal date for this application was 2026-09-18. Verify against the linked primary source.
What is NUVL's drug Zidesamtinib (NVL-520)?
Zidesamtinib (NVL-520) is Nuvalent Inc.'s drug, approved by the FDA on July 22, 2026 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.