FDA Accepts Gilead's SNDA For Once-Weekly Oral Yeztugo In HIV PrEP; PDUFA Set For February 2027

Gilead Sciences said the FDA accepted its supplemental NDA for Yeztugo (lenacapavir) for HIV pre-exposure prophylaxis, setting a Prescription Drug User Fee Act review date. The filing advances a potential label expansion for the drug and is a constructive regulatory step for the company. The news is positive for Gilead, though the article does not indicate an approval decision yet.

Analysis

Gilead Sciences said the FDA accepted its supplemental NDA for Yeztugo (lenacapavir) for HIV pre-exposure prophylaxis, setting a Prescription Drug User Fee Act review date. The filing advances a potential label expansion for the drug and is a constructive regulatory step for the company. The news is positive for Gilead, though the article does not indicate an approval decision yet.