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.↗ source
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.