Yeztugo (lenacapavir) is a Gilead Sciences, Inc. program in HIV pre-exposure prophylaxis (PrEP). Its PDUFA date is Feb 2, 2027, the FDA's goal date to complete review of the application. 1 FDA decision on record below. Every date links its source.
Indication under review: HIV pre-exposure prophylaxis (PrEP). Sponsor: Gilead Sciences, Inc. (GILD). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 1 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Yeztugo (lenacapavir)'s next FDA decision or readout?
Yeztugo (lenacapavir)'s PDUFA date is Feb 2, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Yeztugo (lenacapavir)'s most recent FDA decision?
On Jun 18, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is Yeztugo (lenacapavir) used for?
In our records Yeztugo (lenacapavir) is under review or in development for HIV pre-exposure prophylaxis (PrEP).
Who makes Yeztugo (lenacapavir)?
Gilead Sciences, Inc. (GILD).
Has Yeztugo (lenacapavir) been approved by the FDA?
Yes. The FDA approved an application for Yeztugo (lenacapavir) on Jun 18, 2025; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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