Gilead Sciences' Yeztugo Drug Application Accepted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Gilead Sciences announced the U.S. FDA accepted its supplemental New Drug Application for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for the prevention of HIV as pre-exposure prophylaxis. The FDA has assigned a Prescription Drug User Fee Act action date of February 2, 2027.
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Analyst Views on GILD
Wall Street analysts forecast GILD stock price to rise
19 Analyst Rating
16 Buy
3 Hold
0 Sell
Strong Buy
Current: 125.450
Low
105.00
Averages
137.88
High
154.00
Current: 125.450
Low
105.00
Averages
137.88
High
154.00
About GILD
Gilead Sciences, Inc. is a biopharmaceutical company. It is engaged in advancing medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. It is focused on discovering, developing, and delivering medicines to address unmet medical needs in virology, oncology, and other therapeutic areas. Its portfolio of marketed products includes AmBisome, Atripla, Biktarvy, Cayston, Complera, Descovy, Descovy for PrEP, Emtriva, Epclusa, Eviplera, Genvoya, Harvoni, Hepcludex, Hepsera, Jyseleca, Letairis, Livdelzi/Lyvdelzi, Odefsey, Sovaldi, Stribild, Sunlenca, Tecartus, Trodelvy, and others. It also sells and distributes authorized generic versions of Epclusa and Harvoni in the United States through its subsidiary, Asegua Therapeutics LLC. It has control on anitocabtagene autoleucel (anito cel), an investigational BCMA-directed CAR T cell therapy for multiple myeloma. The Company also owns an antibody-drug conjugates (ADCs) platform.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Gilead's HIV Prevention Drug Filing Accepted by FDA
- FDA Filing Accepted: Gilead Sciences announced that the FDA has accepted its supplemental new drug application for the weekly oral HIV prevention drug Yeztugo, with a target action date of February 2, 2027, which will provide a more convenient prevention option for high-risk populations and further solidify its leadership in the HIV market.
- Clinical Data Support: The application for Yeztugo is backed by data from the PURPOSE 1 and PURPOSE 2 studies, demonstrating the strong efficacy of lenacapavir across diverse populations, successfully addressing the needs of different patients and potentially increasing Gilead's market share in HIV prevention.
- Sales Forecast Increase: Gilead has raised its 2026 sales forecast for Yeztugo to $1 billion, indicating confidence in the drug's market acceptance and sales potential, with expectations for it to achieve blockbuster status in its first full year post-launch.
- Collaborative Research Progress: Positive results from Gilead's collaboration with Merck in the ISLEND-1 and ISLEND-2 studies support the potential of a new once-weekly oral single-tablet treatment regimen, further advancing Gilead's HIV treatment pipeline and enhancing its competitive position in the market.
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Gilead's Yeztugo Receives FDA Acceptance for HIV Prevention
- FDA Application Acceptance: Gilead's supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) as a pre-exposure prophylaxis (PrEP) for HIV prevention has been accepted by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for February 2, 2027, potentially offering a new option for HIV prevention.
- New Formulation Development: The current sNDA is for a 300 mg oral tablet of Yeztugo to be taken once weekly, which, if approved, would become the first long-acting oral PrEP option, further expanding Gilead's market share in HIV prevention.
- Clinical Trial Support: The acceptance of the application is backed by results from the PURPOSE 1 and PURPOSE 2 trials, demonstrating efficacy across diverse populations, including cisgender women, cisgender men, and gender-diverse individuals, indicating its broad applicability.
- Strong Financial Performance: Gilead reported total revenue of $29.443 billion for 2025, up from $28.754 billion in 2024, primarily driven by growth in sales of HIV and liver disease products, showcasing the company's robust performance in the biopharmaceutical sector.
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Gilead's Application for Weekly HIV Prevention Pill Accepted by FDA
- FDA Review Acceptance: The US FDA has accepted Gilead Sciences' (GILD) application for a once-weekly oral version of Yeztugo (lenacapavir) for HIV pre-exposure prophylaxis, with an action date set for February 2, 2027, potentially enhancing convenience in HIV prevention.
- Clinical Trial Backing: The application is supported by data from the PURPOSE 1 and PURPOSE 2 trials, demonstrating the new formulation's efficacy in preventing HIV, which may attract more high-risk populations to utilize the treatment.
- Product Transformation: Yeztugo is currently approved as an injection with subsequent doses administered every six months, and transitioning to an oral formulation is expected to improve patient adherence, thereby driving sales growth.
- Market Potential: With the rising demand for HIV prevention, Gilead's new drug is poised to capture a significant market share, further solidifying its leadership position in the antiviral drug sector.
See More
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- Intensifying Market Competition: At the conference in New Orleans, Eli Lilly and Novo Nordisk showcased their GLP-1 drugs, with Novo's Wegovy prescriptions exceeding 3 million within five months of launch, indicating that oral medications are attracting more consumers and could reshape the weight loss drug market.
- New Drug Development Updates: Structure Therapeutics and AstraZeneca shared mid-stage data, and if their GLP-1 drugs succeed in Phase 3 trials, they are expected to hit the market by 2029, further enriching market options and intensifying competition.
- Innovative Administration Methods: Pfizer's new drug shows potential for monthly administration, which could be more convenient than current weekly injections, while Amgen is testing a drug that could be administered monthly or quarterly, aiming to enhance patient adherence to treatment.
- Future Market Outlook: With approximately 2.5 billion people globally classified as overweight and 890 million as obese, the competition will intensify as new drugs continue to emerge, while Lilly and Novo are also working to improve insurance coverage for GLP-1 drugs, which is expected to attract more patients.
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- Accelerated Drug Access: On June 5, 2026, Gilead Sciences praised the South African government and the Global Fund for expediting access to lenacapavir, with CEO Daniel O’Day emphasizing South Africa's critical role in global HIV efforts, showcasing the company's commitment to public health initiatives.
- Significant Clinical Trial Results: On June 2, 2026, Gilead announced Phase 3 results for Livdelzi in primary biliary cholangitis, demonstrating a significant increase in patients achieving ALP normalization after 52 weeks compared to placebo, further supporting the drug's efficacy and safety profile.
- Long-term Efficacy Analysis: In the ongoing ASSURE study, Gilead shared post hoc analysis data showing that among 50 participants, 83% achieved ALP normalization at 12 months and 74% at 24 months, indicating Livdelzi's long-term efficacy and good tolerability without treatment discontinuations due to adverse events.
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See More
Gilead's HIV Prevention Drug Filing Accepted by FDA
- FDA Filing Accepted: Gilead Sciences announced that the FDA has accepted its supplemental new drug application for the weekly oral HIV prevention drug Yeztugo, with a target action date of February 2, 2027, which will provide a more convenient prevention option for high-risk populations and further solidify its leadership in the HIV market.
- Clinical Data Support: The application for Yeztugo is backed by data from the PURPOSE 1 and PURPOSE 2 studies, demonstrating the strong efficacy of lenacapavir across diverse populations, successfully addressing the needs of different patients and potentially increasing Gilead's market share in HIV prevention.
- Sales Forecast Increase: Gilead has raised its 2026 sales forecast for Yeztugo to $1 billion, indicating confidence in the drug's market acceptance and sales potential, with expectations for it to achieve blockbuster status in its first full year post-launch.
- Collaborative Research Progress: Positive results from Gilead's collaboration with Merck in the ISLEND-1 and ISLEND-2 studies support the potential of a new once-weekly oral single-tablet treatment regimen, further advancing Gilead's HIV treatment pipeline and enhancing its competitive position in the market.
See More
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- Rackspace and AMD Partnership: Rackspace announced a collaboration to deploy 30 megawatts of AMD computing capacity across its data centers, resulting in a 9% stock price increase for Rackspace while AMD shares fell 4%, indicating mixed market reactions to the partnership.
- Mobileye's Autonomous Ride-Hailing: Mobileye plans to launch an autonomous ride-hailing service in a U.S. city by 2027, with shares rising nearly 3%, suggesting that this new initiative could significantly enhance its market share and brand presence in the driver-assist technology sector.
- Southwest Airlines Stock Surge: Southwest Airlines shares rose almost 4% after Jefferies raised its price target from $37 to $44, although the new target still indicates a 4.5% downside from Monday's close, reflecting optimistic sentiment regarding the airline industry's recovery.
- Gildan's Stock Plunge: Gildan's stock plummeted about 24% following a negative report from Jehoshaphat Research, which claimed the company's
See More
Gilead's Yeztugo Receives FDA Acceptance for HIV Prevention
- FDA Application Acceptance: Gilead's supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) as a pre-exposure prophylaxis (PrEP) for HIV prevention has been accepted by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for February 2, 2027, potentially offering a new option for HIV prevention.
- New Formulation Development: The current sNDA is for a 300 mg oral tablet of Yeztugo to be taken once weekly, which, if approved, would become the first long-acting oral PrEP option, further expanding Gilead's market share in HIV prevention.
- Clinical Trial Support: The acceptance of the application is backed by results from the PURPOSE 1 and PURPOSE 2 trials, demonstrating efficacy across diverse populations, including cisgender women, cisgender men, and gender-diverse individuals, indicating its broad applicability.
- Strong Financial Performance: Gilead reported total revenue of $29.443 billion for 2025, up from $28.754 billion in 2024, primarily driven by growth in sales of HIV and liver disease products, showcasing the company's robust performance in the biopharmaceutical sector.
See More
Gilead's Application for Weekly HIV Prevention Pill Accepted by FDA
- FDA Review Acceptance: The US FDA has accepted Gilead Sciences' (GILD) application for a once-weekly oral version of Yeztugo (lenacapavir) for HIV pre-exposure prophylaxis, with an action date set for February 2, 2027, potentially enhancing convenience in HIV prevention.
- Clinical Trial Backing: The application is supported by data from the PURPOSE 1 and PURPOSE 2 trials, demonstrating the new formulation's efficacy in preventing HIV, which may attract more high-risk populations to utilize the treatment.
- Product Transformation: Yeztugo is currently approved as an injection with subsequent doses administered every six months, and transitioning to an oral formulation is expected to improve patient adherence, thereby driving sales growth.
- Market Potential: With the rising demand for HIV prevention, Gilead's new drug is poised to capture a significant market share, further solidifying its leadership position in the antiviral drug sector.
See More
Future Outlook for Obesity Drugs Market
- Intensifying Market Competition: At the conference in New Orleans, Eli Lilly and Novo Nordisk showcased their GLP-1 drugs, with Novo's Wegovy prescriptions exceeding 3 million within five months of launch, indicating that oral medications are attracting more consumers and could reshape the weight loss drug market.
- New Drug Development Updates: Structure Therapeutics and AstraZeneca shared mid-stage data, and if their GLP-1 drugs succeed in Phase 3 trials, they are expected to hit the market by 2029, further enriching market options and intensifying competition.
- Innovative Administration Methods: Pfizer's new drug shows potential for monthly administration, which could be more convenient than current weekly injections, while Amgen is testing a drug that could be administered monthly or quarterly, aiming to enhance patient adherence to treatment.
- Future Market Outlook: With approximately 2.5 billion people globally classified as overweight and 890 million as obese, the competition will intensify as new drugs continue to emerge, while Lilly and Novo are also working to improve insurance coverage for GLP-1 drugs, which is expected to attract more patients.
See More
Gilead Sciences Accelerates HIV Drug Access in South Africa
- Accelerated Drug Access: On June 5, 2026, Gilead Sciences praised the South African government and the Global Fund for expediting access to lenacapavir, with CEO Daniel O’Day emphasizing South Africa's critical role in global HIV efforts, showcasing the company's commitment to public health initiatives.
- Significant Clinical Trial Results: On June 2, 2026, Gilead announced Phase 3 results for Livdelzi in primary biliary cholangitis, demonstrating a significant increase in patients achieving ALP normalization after 52 weeks compared to placebo, further supporting the drug's efficacy and safety profile.
- Long-term Efficacy Analysis: In the ongoing ASSURE study, Gilead shared post hoc analysis data showing that among 50 participants, 83% achieved ALP normalization at 12 months and 74% at 24 months, indicating Livdelzi's long-term efficacy and good tolerability without treatment discontinuations due to adverse events.
- Market Potential Assessment: While Gilead is recognized as a promising investment, analysts suggest that certain AI stocks may offer greater upside potential and lower downside risk, reflecting a diversified view of investment opportunities across different sectors.
See More
