Gilead Sciences Inc.

GILD

Held by 3 specialist biotech funds

High Convergence

3 funds opened new positions. Next phase3 readout (Oral Lenacapavir): Oct 2020. Short interest: 1.9% of float.

Drug Manufacturers - GeneralCEO: Daniel O'DayIPO: 1992Website ↗

Gilead Sciences, Inc., a biopharmaceutical company, discovers, develops, and commercializes medicines in the areas of unmet medical need in the United States, Europe, and internationally. The company provides Biktarvy, Genvoya, Descovy, Odefsey, Truvada, Complera/ Eviplera, Stribild, and Atripla products for the treatment of HIV/AIDS; Veklury, an injection for intravenous use, for the treatment of coronavirus disease 2019; and Epclusa, Harvoni, Vosevi, Vemlidy, and Viread for the treatment of liver diseases. It also offers Yescarta, Tecartus, Trodelvy, and Zydelig products for the treatment of hematology, oncology, and cell therapy patients. In addition, the company provides Letairis, an oral formulation for the treatment of pulmonary arterial hypertension; Ranexa, an oral formulation for the treatment of chronic angina; and AmBisome, a liposomal formulation for the treatment of serious invasive fungal infections. Gilead Sciences, Inc. has collaboration agreements with Arcus Biosciences, Inc.; Pionyr Immunotherapeutics Inc.; Tizona Therapeutics, Inc.; Tango Therapeutics, Inc.; Jounce Therapeutics, Inc.; Galapagos NV; Janssen Sciences Ireland Unlimited Company; Japan Tobacco, Inc.; Gadeta B.V.; Bristol-Myers Squibb Company; Dragonfly Therapeutics, Inc.; and Merck & Co, Inc. The company was incorporated in 1987 and is headquartered in Foster City, California.

Catalysts

Phase 3PositiveQ4 2020Oral LenacapavirHIV-1-infectionNCT04150068

Primary: Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period (Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15)Enrollment:72/72Sites: 75RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2021Sacituzumab Govitecan-hziyMetastatic Triple-negative Breast CancerNCT04454437

Primary: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Independent Review Committee (IRC) (Up to 3 years)Enrollment:80/80Sites: 17NA, TREATMENT

Phase 2PositiveQ3 2024TeropavimabHIV-1 InfectionNCT05729568

Phase 3Q2 2025ATVAcquired Immune Deficiency Syndrome (AIDS), HIV InfectionsNCT02016924

Phase 3Q4 2025BictegravirHIV-1-infectionNCT06333808

Phase 3Q2 2026ISL/LENHIV-1-InfectionNCT06630299

Phase 2Q2 2026Sacituzumab Govitecan-hziyAdvanced Solid Tumor, Metastatic Triple-Negative Breast Cancer, HR+/HER2- Metastatic Breast CancerNCT05101096

Phase 2Q2 2026Lenacapavir InjectionPre-Exposure Prophylaxis of HIV InfectionNCT06513312

Phase 2Q1 2027Oral LenacapavirHIV-1-infectionNCT06749054

Phase 2Q4 2027DomvanalimabAdvanced Non-Small Cell Lung CancerNCT05676931

Phase 2Q1 2028Lenacapavir InjectionPre-Exposure Prophylaxis of HIV InfectionNCT06101342

Phase 2Q2 2028Sacituzumab Govitecan-hziy (SG)Triple Negative Breast CancerNCT06926920

Phase 3Q4 2028Seladelpar 5 mg CapsulePrimary Biliary CirrhosisNCT03301506

Phase 2Q4 2028DenikitugAdvanced Microsatellite Stable Colorectal CancerNCT07527858

Phase 2Q1 2029GS-4321Chronic Hepatitis DeltaNCT07096193

Phase 2Q3 2029Zimberelimab (ZIM)Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung CancerNCT05633667

Phase 2Q1 2030DenikitugHER2-negative, Gastroesophageal Junction, Esophageal AdenocarcinomaNCT07546812

Phase 2Q2 2030Sacituzumab Govitecan-hziyMetastatic Urothelial CancerNCT03547973

Phase 3Q2 2031KITE-753Relapsed or Refractory Large B-cell LymphomaNCT07479797

Recent News & Research

PubMed

Renal outcomes with dolutegravir plus lamivudine versus bictegravir/emtricitabine/tenofovir alafenamide in ART-naive adults with HIV.

# Investment Summary: Gilead Renal Safety Data This study compares renal outcomes between dolutegravir/lamivudine and Gilead's bictegravir/FTC/TAF regimen in treatment-naive HIV patients, directly benchmarking Gilead's preferred backbone against a competitor formulation. The renal safety profile of TAF (tenofovir alafenamide)—a key Gilead differentiator marketed as superior to older tenofovir formulations—appears central to the competitive positioning of Gilead's single-tablet regimen in a mature HIV market. Results favoring or matching Gilead's regimen would reinforce TAF's clinical value proposition; unfavorable outcomes could pressure market share in first-line therapy, where renal safety increasingly influences treatment selection.

May 4, 2026

PubMed

Metabolic outcomes of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir/lamivudine in treatment-naïve people living with HIV: a 48-week retrospective study.

# Investment Summary: Gilead's BIC/F/TAF vs. Competitor DTG/3TC This retrospective study compares metabolic outcomes between Gilead's bictegravir-based regimen (BIC/F/TAF) and dolutegravir/lamivudine (a competitor combination) over 48 weeks in treatment-naïve HIV patients, with implications for differentiation in a competitive first-line therapy market. The metabolic profile comparison is clinically relevant given growing physician and patient focus on long-term tolerability and comorbidity risk (lipids, glucose, bone health), which influence treatment selection and adherence. Results favoring Gilead's formulation could strengthen market positioning for BIC/F/TAF against DTG-based competitors, though the retroactive design limits the evidence strength compared to prospective randomized trials. **Why it matters:** Metabolic safety increasingly

May 4, 2026

PubMed

Bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir plus lamivudine plus tenofovir disoproxil fumarate in people living with HIV experiencing virologic failure in China: a study protocol for a multicenter, open-label, randomized controlled non-inferiority trial.

# Investment Summary: Gilead's Bictegravir/FTC/TAF Trial in China **Clinical/Commercial Relevance:** This trial compares Gilead's single-tablet regimen (bictegravir/FTC/TAF) against a competitor's multi-drug combination in treatment-experienced Chinese HIV patients with virologic failure—a population segment representing potential market expansion and switching opportunities in a region with growing treatment-resistant cases. Success would validate Gilead's integrase inhibitor portfolio in treatment-experienced settings and support pricing/reimbursement arguments in China's expanding HIV market, though China's price-controlled environment limits upside relative to Western markets. **Investor Implications:** The trial design addresses a clinically relevant but smaller patient segment; meaningful revenue impact depends on trial outcomes, regulatory approval timelines in China, and competitive dynamics with Dolutegravir-based regimens that dominate

May 1, 2026

PubMed

The Safety and Effectiveness of B/F/TAF for HIV-1 in a Prospective Multicenter Observational Study in the Republic of Korea.

# Investment Summary: Gilead's B/F/TAF in Korean Market This prospective observational study demonstrates B/F/TAF (bictegravir/emtricitabine/tenofovir alafenamide—Gilead's single-tablet regimen) maintains safety and efficacy in a real-world Korean HIV-1 patient population, supporting label extension and market penetration in an important Asian market. The data validates B/F/TAF's clinical profile outside pivotal trial populations, which could strengthen reimbursement arguments and expand addressable market in countries with growing treatment-naive and treatment-experienced populations. This geographic expansion evidence is commercially relevant as Asia-Pacific markets represent significant growth opportunities for Gilead's HIV franchise amid competition from long-acting injectables and other integrase inhibitors.

Apr 30, 2026

Gilead Sciences Inc.

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