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FDA Accepts Gilead's Filing for Weekly Oral Yeztugo for HIV Prevention
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Key Takeaways
FDA accepted GILD's sNDA for once-weekly oral Yeztugo for HIV prevention; decision due Feb. 2, 2027.
PURPOSE studies showed strong lenacapavir efficacy for HIV prevention across diverse populations.
Gilead raised its 2026 Yeztugo sales forecast to $1 billion following strong market uptake.
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral pre-exposure prophylaxis (PrEP) option for HIV prevention.
The FDA has set a target action date of Feb. 2, 2027.
We note that Yeztugo (lenacapavir) twice-yearly injection is already approved in the United States for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents who are at risk for HIV-1 acquisition.
Gilead’s shares have gained 1.3% year to date against the industry's decline of 1.3%.
Image Source: Zacks Investment Research
More on GILD’s Once Weekly Yeztugo
The submission is supported by data from the PURPOSE 1 and PURPOSE 2 studies, which demonstrated strong efficacy of lenacapavir for HIV prevention across diverse populations, including cisgender women, cisgender men and gender-diverse individuals.
Oral lenacapavir tablets are already part of the approved Yeztugo regimen as a loading dose and as temporary bridge therapy when the twice-yearly injectable schedule is delayed.
GILD is seeking to build on lenacapavir’s established clinical profile by expanding its long-acting HIV prevention portfolio with new formulations.
The company aims to increase access to PrEP by offering prevention options tailored to diverse patient preferences and needs. If approved, once-weekly oral Yeztugo would provide an additional, convenient PrEP alternative, reflecting the view that HIV prevention requires a range of individualized approaches.
GILD’s Efforts to Diversify Portfolio
Gilead maintains a leading position in the HIV market, anchored by its flagship products, Biktarvy for HIV treatment and Descovy for HIV prevention. Biktarvy is a once-daily, single-tablet regimen that combines bictegravir, a potent integrase strand transfer inhibitor (INSTI), with the Descovy backbone of emtricitabine and tenofovir alafenamide.
The approval of Yeztugo in 2025 has further strengthened Gilead’s HIV portfolio. Unlike traditional daily oral PrEP medications, Yeztugo is administered just twice a year, offering a more convenient prevention option for many patients.
Driven by strong first-quarter sales and favorable market uptake, Gilead recently increased its 2026 sales forecast for Yeztugo to $1 billion, putting the drug on track to attain blockbuster status in its first full year following its launch.
The company’s HIV business also benefits from a lengthy exclusivity runway, with no major patent expirations expected before 2036. Combined with plans to introduce as many as seven new HIV therapies by 2033, Gilead appears well positioned to sustain long-term growth in its core HIV franchise.
GILD has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline further.
Gilead and Merck recently reported positive results from the phase III ISLEND-1 and ISLEND-2 studies evaluating an investigational once-weekly oral single-tablet regimen combining islatravir and lenacapavir for HIV treatment.
The regimen pairs Merck’s islatravir, a next-generation nucleoside analog that suppresses HIV replication through multiple mechanisms, including reverse transcriptase translocation inhibition, with Gilead’s long-acting capsid inhibitor lenacapavir.
Both trials achieved their primary efficacy endpoint at week 48, supporting the potential of a convenient once-weekly treatment option. Following these results, the partners plan to submit the ISLEND data to global regulatory agencies and present detailed findings at an upcoming scientific meeting.
Gilead Sciences, Inc. Price, Consensus and EPS Surprise
Beyond the Merck partnership, Gilead continues to advance its wholly owned HIV pipeline. Earlier this year, the company reported promising phase I results for GS-3242, a long-acting integrase inhibitor. Additional data expected later in 2026 could pave the way for a twice-yearly injectable regimen combining GS-3242 with lenacapavir, further strengthening Gilead’s HIV portfolio.
Approval of additional better treatments should bolster GILD’s HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.
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FDA Accepts Gilead's Filing for Weekly Oral Yeztugo for HIV Prevention
Key Takeaways
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral pre-exposure prophylaxis (PrEP) option for HIV prevention.
The FDA has set a target action date of Feb. 2, 2027.
We note that Yeztugo (lenacapavir) twice-yearly injection is already approved in the United States for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents who are at risk for HIV-1 acquisition.
Gilead’s shares have gained 1.3% year to date against the industry's decline of 1.3%.
Image Source: Zacks Investment Research
More on GILD’s Once Weekly Yeztugo
The submission is supported by data from the PURPOSE 1 and PURPOSE 2 studies, which demonstrated strong efficacy of lenacapavir for HIV prevention across diverse populations, including cisgender women, cisgender men and gender-diverse individuals.
Oral lenacapavir tablets are already part of the approved Yeztugo regimen as a loading dose and as temporary bridge therapy when the twice-yearly injectable schedule is delayed.
GILD is seeking to build on lenacapavir’s established clinical profile by expanding its long-acting HIV prevention portfolio with new formulations.
The company aims to increase access to PrEP by offering prevention options tailored to diverse patient preferences and needs. If approved, once-weekly oral Yeztugo would provide an additional, convenient PrEP alternative, reflecting the view that HIV prevention requires a range of individualized approaches.
GILD’s Efforts to Diversify Portfolio
Gilead maintains a leading position in the HIV market, anchored by its flagship products, Biktarvy for HIV treatment and Descovy for HIV prevention. Biktarvy is a once-daily, single-tablet regimen that combines bictegravir, a potent integrase strand transfer inhibitor (INSTI), with the Descovy backbone of emtricitabine and tenofovir alafenamide.
The approval of Yeztugo in 2025 has further strengthened Gilead’s HIV portfolio. Unlike traditional daily oral PrEP medications, Yeztugo is administered just twice a year, offering a more convenient prevention option for many patients.
Driven by strong first-quarter sales and favorable market uptake, Gilead recently increased its 2026 sales forecast for Yeztugo to $1 billion, putting the drug on track to attain blockbuster status in its first full year following its launch.
The company’s HIV business also benefits from a lengthy exclusivity runway, with no major patent expirations expected before 2036. Combined with plans to introduce as many as seven new HIV therapies by 2033, Gilead appears well positioned to sustain long-term growth in its core HIV franchise.
GILD has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline further.
Gilead and Merck recently reported positive results from the phase III ISLEND-1 and ISLEND-2 studies evaluating an investigational once-weekly oral single-tablet regimen combining islatravir and lenacapavir for HIV treatment.
The regimen pairs Merck’s islatravir, a next-generation nucleoside analog that suppresses HIV replication through multiple mechanisms, including reverse transcriptase translocation inhibition, with Gilead’s long-acting capsid inhibitor lenacapavir.
Both trials achieved their primary efficacy endpoint at week 48, supporting the potential of a convenient once-weekly treatment option. Following these results, the partners plan to submit the ISLEND data to global regulatory agencies and present detailed findings at an upcoming scientific meeting.
Gilead Sciences, Inc. Price, Consensus and EPS Surprise
Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. Quote
Beyond the Merck partnership, Gilead continues to advance its wholly owned HIV pipeline. Earlier this year, the company reported promising phase I results for GS-3242, a long-acting integrase inhibitor. Additional data expected later in 2026 could pave the way for a twice-yearly injectable regimen combining GS-3242 with lenacapavir, further strengthening Gilead’s HIV portfolio.
Approval of additional better treatments should bolster GILD’s HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.
GILD’s Zacks Rank
Gilead currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.