NASDAQ — Healthcare: Manufacturing, Drug Manufacturers - General: Biological Products (No Disgnostic Substances)
www.gilead.comThe FDA has set a PDUFA date for lenacapavir, a drug for HIV prevention, which is anticipated to be a significant milestone for Gilead.
fda decisionA Phase 1b/2 clinical trial evaluating etrumadenant-based combination therapies in metastatic colorectal cancer is expected to complete by July 1, 2025. The study, sponsored by Arcus Biosciences in collaboration with Gilead Sciences, is assessing the safety and antitumor activity of etrumadenant in various regimens, including combinations with zimberelimab, mFOLFOX-6, bevacizumab, and other agents. Etrumadenant is an investigational dual adenosine receptor antagonist targeting immuno-oncology pathways.
trial completionA phase 2 clinical trial evaluating zimberelimab (AB122) monotherapy and combinations with domvanalimab (AB154) and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer (NSCLC) is expected to complete by August 1, 2025. The study, sponsored by Arcus Biosciences and involving Gilead Sciences, aims to assess safety and efficacy of these immunotherapies in 151 participants. The trial's outcome may inform future regulatory and commercial strategies for these investigational cancer therapies.
trial completionArcus Biosciences is conducting a Phase 1/1b clinical trial evaluating AB308 in combination with zimberelimab (AB122) in patients with advanced malignancies. The study, which began in March 2021, is expected to complete on September 1, 2025. The trial aims to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity. Gilead Sciences has a partnership with Arcus for immuno-oncology assets, making this trial relevant for both companies. AB308 is a TIM-3 antibody, and AB122 (zimberelimab) is a PD-1 inhibitor, both targeting immune checkpoint pathways.
trial completionA Phase 3 clinical trial evaluating domvanalimab (TIGIT monoclonal antibody) and zimberelimab (PD-1 monoclonal antibody) plus chemotherapy versus nivolumab plus chemotherapy in first-line treatment of advanced or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma is expected to complete on May 1, 2026. The study, sponsored by Arcus Biosciences and involving Gilead Sciences through partnership, targets patients with unresectable or metastatic upper GI cancers. Domvanalimab and zimberelimab are investigational immunotherapies designed to enhance anti-tumor immune response.
trial completionThe MORPHEUS-UC Phase Ib/II clinical trial, sponsored by Hoffmann-La Roche, is expected to complete on May 21, 2026. The study evaluates the efficacy and safety of multiple immunotherapy-based treatments and combinations in patients with muscle-invasive and metastatic urothelial carcinoma who have progressed after platinum-containing regimens. The trial uses an adaptive, umbrella design to test various regimens and adjust arms based on emerging data. Gilead Sciences (GILD) is not listed as a sponsor or primary participant in this trial.
trial completionGilead Sciences is conducting a Phase 2 platform study evaluating novel treatment combinations, including domvanalimab and zimberelimab with chemotherapy, for first-line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The trial, which began in February 2025, is expected to complete on August 1, 2026. The study aims to assess the efficacy and safety of these regimens versus standard zimberelimab plus chemotherapy. Additional substudies and drugs may be added as data become available.
trial completionA phase III clinical trial evaluating high-dose liposomal amphotericin B for induction therapy in AIDS-related disseminated histoplasmosis is expected to complete on November 28, 2026. The study, sponsored by the Federal University of Health Science of Porto Alegre with financial and drug support from Gilead Sciences, aims to assess non-inferiority and potential superiority of a single 10 mg/kg dose versus standard 3 mg/kg dosing over two weeks. Liposomal amphotericin B is an antifungal agent used in severe fungal infections, and the trial's outcome could impact treatment protocols for immunocompromised patients.
trial completionGilead Sciences is conducting a Phase 2 platform clinical trial (NCT05633667) evaluating novel treatment combinations for non-small-cell lung cancer (NSCLC). The study includes multiple substudies comparing investigational regimens to standard of care in both treatment-naïve and previously treated metastatic NSCLC, as well as resectable stage II-III NSCLC. The trial is expected to complete by January 1, 2027. Primary endpoints include objective response rate and complete pathological response rate. The study is currently recruiting with an enrollment target of 593 participants.
trial completionA phase 2 clinical trial evaluating zimberelimab (AB122) and domvanalimab (AB154) in combination for first-line treatment of PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC) is expected to complete on May 1, 2027. The study, sponsored by Arcus Biosciences and partnered with Gilead Sciences, is assessing efficacy and safety in 169 patients. Zimberelimab and domvanalimab are investigational immunotherapies targeting PD-1 and TIGIT, respectively, and represent a potential new combination approach in lung cancer treatment.
trial completion