Yeztugo (lenacapavir)
Q2 2026 sales of $232 million, up from $15 million a year earlier. Once-weekly oral filing has an FDA date of February 2, 2027.
The numbers
What it is
Yeztugo is a twice-yearly injection approved on June 18, 2025 to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg. The FDA has accepted a supplemental application for a once-weekly oral version, with a target action date of February 2, 2027.
Why it matters to the stock. Yeztugo is Gilead's main new HIV growth product. The oral filing is the next test of whether lenacapavir can become a broader franchise.
News
Gilead widens royalty-free lenacapavir licences to cover once-yearly HIV prevention
Gilead expanded six existing royalty-free voluntary licences for lenacapavir to cover the investigational once-yearly injection for HIV prevention, across 120 high-incidence countries, mostly low- and lower-middle-income.
FDA accepts application for once-weekly oral Yeztugo, PDUFA date February 2, 2027
The FDA accepted Gilead's supplemental application for a once-weekly oral 300 mg lenacapavir tablet for HIV prevention, with a PDUFA action date of February 2, 2027.
Gilead Q1 2026 beats: product sales ex-Veklury up 8%, product guidance raised, EPS guidance cut to a loss
Gilead's first-quarter revenue rose 4% to $6.96 billion, and product sales excluding Veklury grew 8% to $6.8 billion.