Key Takeaways:
- FDA accepted Gilead's sNDA for once-weekly oral Yeztugo for HIV prevention
- PDUFA target action date set for Feb. 2, 2027
- If approved, it would become the first long-acting oral PrEP option
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Gilead seeks FDA nod for weekly oral Yeztugo with February 2027 target
The U.S. Food and Drug Administration accepted Gilead Sciences Inc.'s application for once-weekly oral Yeztugo (lenacapavir) as a pre-exposure prophylaxis option for HIV prevention, setting a Feb. 2, 2027, target action date.
"The filing reflects Gilead's continued commitment to advancing new HIV prevention options," Dietmar Berger, chief medical officer at Gilead Sciences, said in a statement. "Nearly one year after the approval of twice-yearly Yeztugo, we are building on the established clinical profile of lenacapavir to potentially extend the impact of our long-acting innovation into new formulations."
The submission is supported by data from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated high efficacy across diverse populations including cisgender women, cisgender men and gender-diverse people. Lenacapavir oral tablets are already approved as a loading dose and bridge therapy within the twice-yearly injectable Yeztugo regimen. If approved, once-weekly oral Yeztugo would become the first long-acting oral PrEP option, offering an alternative to daily pills and the twice-yearly shot.
Gilead's HIV franchise remains the company's core growth driver. Biktarvy holds more than 52% of the HIV treatment market, and the company raised its 2026 Yeztugo sales forecast to $1 billion in May, putting the drug on track for blockbuster status in its first full year. The company expects total 2026 HIV sales growth of approximately 8% year over year, with no major patent expirations before 2036 and as many as seven new HIV therapies planned by 2033.
The approval would strengthen Gilead's position against competitors including GSK plc's ViiV Healthcare, which markets long-acting injectable Cabenuva and Apretude but lacks a weekly oral option. Merck & Co. recently won FDA approval of Idvynso, a once-daily two-drug regimen for HIV treatment, and is collaborating with Gilead on an investigational once-weekly oral treatment combining islatravir and lenacapavir that met primary efficacy endpoints in two Phase 3 studies. Gilead shares have gained 2.3% year to date.
This article is for informational purposes only and does not constitute investment advice.
