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)
Daily close, T-120 (3/6/26) through T+1. Run-up high $148.77 on 8/25/26, low $121.48 on 6/10/26 (T-120 to T-1). FDA decision 8/27/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-08-27
OutcomeApproved
Drug / candidateBixlenvo (bictegravir 75 mg / lenacapavir 50 mg)
IndicationHIV-1 in virologically suppressed adults, once-daily single-tablet regimen for those on complex regimens
CompanyGilead Sciences, Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)+2.9%
Cohort decision-day move (history)1.0% median (n=828)
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.
Was Bixlenvo (bictegravir 75 mg / lenacapavir 50 mg) approved by the FDA?
Yes. The FDA approved the application for Bixlenvo (bictegravir 75 mg / lenacapavir 50 mg) on August 27, 2026. The primary source is linked on this page.
Which company is behind Bixlenvo (bictegravir 75 mg / lenacapavir 50 mg)?
Bixlenvo (bictegravir 75 mg / lenacapavir 50 mg) is a Gilead Sciences, Inc. (GILD) program. The FDA decision came on August 27, 2026; the company's own announcement is linked on this page.
How did GILD stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), GILD moved +2.9%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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