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Home › PDUFA Calendar › GILD

GILD PDUFA Date: Bictegravir and Lenacapavir

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on August 27, 2026 on its goal date. Decision page with the source and measured reaction.
FDA decision Approved August 27, 2026 · Gilead Sciences Inc. · HIV
More Infectious Disease FDA decisions →All August 2026 PDUFA dates →

The story

Bictegravir and Lenacapavir was approved by the FDA on August 27, 2026 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 decisionApproved August 27, 2026
FDA goal date2026-08-27
Drug / candidateBictegravir and Lenacapavir
IndicationHIV
CompanyGilead Sciences Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT06333808 · active

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See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on GILD's Bictegravir and Lenacapavir?
The FDA decided GILD's (Gilead Sciences Inc.) application for Bictegravir and Lenacapavir on August 27, 2026: Approved. The FDA goal date for this application was 2026-08-27. Verify against the linked primary source.
What is GILD's drug Bictegravir and Lenacapavir?
Bictegravir and Lenacapavir is Gilead Sciences Inc.'s drug, approved by the FDA on August 27, 2026 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.