GILD FDA decision: Aug 27, 2026

Bictegravir and Lenacapavir was approved by the FDA on August 27, 2026 for HIV.

Bixlenvo (bictegravir/lenacapavir) approved on August 27, 2026 - its PDUFA goal date - as a once-daily single-tablet HIV regimen for virologically suppressed adults on complex regimens.

Run-up into the decision (T-120 → T+5)

Key facts

The PDUFA target action date was August 27, 2026 and the FDA approved the NDA that day, under Priority Review. Bixlenvo combines bictegravir 75 mg with lenacapavir 50 mg as the smallest once-daily single-tablet regimen for HIV, and is the first single-tablet option for virologically suppressed adults who cannot take currently available single-tablet regimens. The approval rests on the Phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, first presented at CROI 2026: both showed comparable maintenance of virologic suppression at Week 48 against continuing the prior regimen, with no new safety signals. This is lenacapavir's third FDA-approved use after Sunlenca and Yeztugo.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: Gilead Sciences press release, August 27, 2026

FDA record of the action: the FDA approved on August 27, 2026, per NDA 221443 S-001 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.