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Home › PDUFA Calendar › GILD

GILD PDUFA Date: Bictegravir and Lenacapavir

Updated ·next FDA decision on the calendar
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

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

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.