Gilead Sciences, Inc. (GILD) announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) for the prevention of HIV as pre-exposure prophylaxis (PrEP) and has set a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027.
On July 18, 2025, the FDA approved the twice-yearly Yeztugo injection, 463.5 mg/1.5 mL, indicated for pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents (> 35 kg) who are at risk for HIV-1 acquisition. The current sNDA is for Yeztugo in 300-mg tablet form as a once-weekly (QW) oral formulation.
The application acceptance was backed by the results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated efficacy across populations, including cisgender women, cisgender men and gender-diverse people. Gilead believes that if approved, once-weekly oral Yeztugo could become the first long-acting oral PrEP option.
For the full year 2025, Gilead reported total revenue of $29.443 billion, up from $28.754 billion in 2024, driven primarily by growth in sales of HIV and liver disease products.
Gilead's commercial portfolio spans HIV, liver disease, oncology, and COVID-19 therapies, while its pipeline includes investigational candidates in these and other therapeutic areas.
As of December 31, 2025, Gilead had $10.6 billion of cash and cash equivalents.
GILD has traded between $104.46 and $157.29 over the last year. The stock closed Monday's trade at $124.30, down 1.03%.
In the overnight market, GILD is down 0.13% at $124.14.
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