The FDA has accepted Gilead Sciences' supplemental new drug application for Yeztugo as a once-weekly oral pre-exposure prophylaxis option for HIV prevention, setting a target action date of February 2, 2027. The submission is supported by data from the PURPOSE 1 and PURPOSE 2 studies, which demonstrated strong efficacy of lenacapavir for HIV prevention across diverse populations. Yeztugo is already approved in the United States as a twice-yearly injection for PrEP, and oral lenacapavir tablets are currently used as a loading dose or temporary bridge therapy. Gilead recently raised its 2026 sales forecast for Yeztugo to $1 billion, putting the drug on track to achieve blockbuster status in its first full year. The company also reported positive phase III results from a collaboration with Merck on a once-weekly oral single-tablet regimen combining islatravir and lenacapavir for HIV treatment, with plans to submit data to global regulators.
Gilead Sciences IncFDA accepted filing for once-weekly oral PrEP, expanding market potential.
Merck & Company IncPositive phase III results for once-weekly oral combo with Gilead; plans to submit to regulators.
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