Gilead’s BIC/LEN HIV Pill Advances with FDA Priority Review; Weekly Oral PrEP Pill sNDA Also Accepted

Gilead Sciences (NASDAQ: GILD) scored two regulatory milestones this week ahead of its HIV portfolio: the FDA has granted priority review to its investigational once‑daily single‑tablet regimen composed of bictegravir plus lenacapavir (BIC/LEN), and has also accepted a supplemental New Drug Application for a potential once‑weekly oral PrEP tablet form of lenacapavir (Yeztugo).

FDA grants priority review to bictegravir/lenacapavir (BIC/LEN)

In the latest development, FDA has accepted the New Drug Application for the combination of bictegravir 75 mg and lenacapavir 50 mg — an investigational once‑daily single‑tablet regimen. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026 and designated the application for priority review.

This investigational regimen is supported by positive Phase 3 data from the ARTISTRY‑1 and ARTISTRY‑2 trials, which showed comparable efficacy in maintaining virologic suppression at Week 48 compared to standard-of-care regimens, without significant new safety concerns. ARTISTRY-1 also showed improved lipid profiles and boosted patient treatment satisfaction, while ARTISTRY‑2 demonstrated no significant impact on weight. Results were initially presented at CROI 2026 and published in The Lancet earlier in 2026.

FDA accepts sNDA for once‑weekly oral lenacapavir PrEP tablet

Separately, the FDA has accepted Gilead’s supplemental NDA filing for a once‑weekly 300 mg oral tablet formulation of Yeztugo (lenacapavir) as a potential HIV pre-exposure prophylaxis (PrEP) option. The agency has set a PDUFA action date of February 2, 2027.

This submission builds upon the established clinical profile of lenacapavir from the PURPOSE 1 and PURPOSE 2 Phase 3 trials, which demonstrated high efficacy and consistent safety across diverse populations, including cisgender women, men, and gender-diverse individuals.

Why these developments matter

The BIC/LEN single‑tablet regimen could become the smallest, once‑daily HIV treatment pill available, offering a high barrier to resistance and improved adherence compared to multi-pill regimens. The once‑weekly oral PrEP option would expand choices for prevention, addressing diverse needs and preferences in HIV care.

These regulatory advances align with Gilead’s broader strategy to extend its leadership in long‑acting HIV therapies — a pillar of its innovation and growth in antivirals.

Looking ahead

Investors and stakeholders will be closely watching whether the FDA meets the August 27, 2026 and February 2, 2027 PDUFA dates, and whether these filings pave the way for new product launches. Approval of these regimens could bolster Gilead’s HIV pipeline and potentially reshape treatment models.

While these developments are significant, their impact on Gilead’s stock performance will depend on the FDA outcomes and market reception. As of September 30, 2026, GILD shares closed at $149.05, down 1.47% on the day.

Note: stock price sourced from verified data as of September 30, 2026.