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Home › PDUFA Calendar › EXEL

EXEL PDUFA Date: XL092 with atezolizumab

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-12-03 · Exelixis Inc. · Colorectal Cancer (CRC)
More Cancer & Oncology FDA decisions →All December 2026 PDUFA dates →

The story

XL092 with atezolizumab is under FDA review to treat Colorectal Cancer (CRC).
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 . TruqapANAB . 2026-12-12Same month decision . Imsidolimab (ANB019)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

$53.5$40.74
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-12-03
Drug / candidateXL092 with atezolizumab
IndicationColorectal Cancer (CRC)
CompanyExelixis Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05425940

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FAQ

When is the EXEL PDUFA date?
The FDA PDUFA target date for EXEL (Exelixis Inc.) is 2026-12-03 for XL092 with atezolizumab. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is EXEL's drug XL092 with atezolizumab?
XL092 with atezolizumab is Exelixis Inc.'s candidate under FDA review for Colorectal Cancer (CRC).
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.