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GILD PDUFA Date: Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab)

FDA decision (PDUFA) target 2026-12-31 · Gilead Sciences Inc. · Inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC)
More Cancer & Oncology FDA decisions →All December 2026 PDUFA dates →

The story

Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) is under FDA review to treat Inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC).
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.

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

$152.74$121.48
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 / candidateTrodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab)
IndicationInoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC)
CompanyGilead Sciences Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05382286

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FAQ

When is the GILD PDUFA date?
The FDA PDUFA target date for GILD (Gilead Sciences Inc.) is 2026-12-31 for Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is GILD's drug Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab)?
Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) is Gilead Sciences Inc.'s candidate under FDA review for Inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.