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Home › PDUFA Calendar › NVS

NVS PDUFA Date: Pluvicto (lutetium (177Lu) vipivotide tetraxetan)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-12-31 · Novartis AG · End-stage prostate cancer
More Cancer & Oncology FDA decisions →All December 2026 PDUFA dates →

The story

Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is under FDA review to treat End-stage prostate cancer.
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 . TruqapEXEL . 2026-12-03Same month decision . XL092 with atezolizumab
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

$168.62$142.94
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-12-31
Drug / candidatePluvicto (lutetium (177Lu) vipivotide tetraxetan)
IndicationEnd-stage prostate cancer
CompanyNovartis AG
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04720157

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FAQ

When is the NVS PDUFA date?
The FDA PDUFA target date for NVS (Novartis AG) is 2026-12-31 for Pluvicto (lutetium (177Lu) vipivotide tetraxetan). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is NVS's drug Pluvicto (lutetium (177Lu) vipivotide tetraxetan)?
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is Novartis AG's candidate under FDA review for End-stage prostate cancer.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.