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GILD PDUFA Date: Bictegravir and Lenacapavir

FDA decision (PDUFA) target 2026-08-27 · Gilead Sciences Inc. · HIV
More Infectious Disease FDA decisions →All August 2026 PDUFA dates →

The story

Bictegravir and Lenacapavir is under FDA review to treat HIV.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthGSK-tebipenem-hbr . 2026-06-18Same area: Infectious disease . Tebipenem HBr (SPR994)SPRO . 2026-06-18Same area: Infectious disease . Tebipenem HBr (SPR994)MRNA . 2026-08-05Same month decision . mRNA-1010
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 date2026-08-27
Drug / candidateBictegravir and Lenacapavir
IndicationHIV
CompanyGilead Sciences Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT06333808 · active
See the full 2026 PDUFA calendar →

FAQ

When is the GILD PDUFA date?
The FDA PDUFA target date for GILD (Gilead Sciences Inc.) is 2026-08-27 for Bictegravir and Lenacapavir. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is GILD's drug Bictegravir and Lenacapavir?
Bictegravir and Lenacapavir is Gilead Sciences Inc.'s candidate under FDA review for HIV.
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.