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Gilead Sciences, Inc. (GILD) is a leading biopharmaceutical company focused on developing innovative therapies for life-threatening diseases. This page provides investors and healthcare professionals with timely updates on the company's latest developments, regulatory milestones, and strategic initiatives.
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Gilead Sciences announced positive results from a Phase 3 trial of Veklury (remdesivir) for treating COVID-19 in non-hospitalized patients at high risk of disease progression. The study, involving 562 participants, showed 87% reduction in hospitalization or all-cause death by Day 28 compared to placebo. Additionally, there was an 81% reduction in medical visits due to COVID-19. No deaths were recorded by Day 28. The findings will be presented at IDWeek 2021. Veklury remains investigational for this use, and safety and efficacy for this dosing duration are pending regulatory approval.
Gilead Sciences (Nasdaq: GILD) will present new data at the IDWeek 2021 conference from September 29 to October 3, focusing on COVID-19 and HIV research. Key presentations include real-world analyses of Veklury (remdesivir), highlighting its effectiveness in hospitalized COVID-19 patients regarding mortality and readmission rates. Additionally, findings on the HIV treatment Biktarvy and prevention strategies to enhance diversity in clinical trials will be shared. Gilead remains committed to advancing treatment options and addressing health disparities in affected communities.
Gilead Sciences (Nasdaq: GILD) announced promising new data from the Phase 3 ASCENT study of Trodelvy in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC). A subgroup analysis revealed that Trodelvy significantly improved progression-free survival (PFS) to 4.6 months vs. 2.3 months with chemotherapy. Overall survival (OS) was also enhanced, with Trodelvy patients living 12.4 months compared to 6.7 months with chemotherapy. The study enrolled over 500 patients and highlighted Trodelvy's efficacy even in non-TNBC patients, reinforcing its role in cancer treatment.
Gilead Sciences announced results from the Phase 3 ASCENT study for Trodelvy (sacituzumab govitecan-hziy) in patients with relapsed or refractory triple-negative breast cancer (TNBC). The study showed Trodelvy improved overall survival (11.8 months vs. 6.9 months, p<0.0001) and significantly enhanced health-related quality of life (HRQoL) compared to physician's choice chemotherapy. Patients reported better global health status and lower symptomatic impacts of fatigue, pain, and insomnia. Trodelvy offers a vital treatment option for this aggressive cancer type.
Gilead Sciences (Nasdaq: GILD) presented new research on Trodelvy (sacituzumab govitecan-hziy) at the ESMO Congress 2021, highlighting its efficacy in treating metastatic triple-negative breast cancer (TNBC). The data from the Phase 3 ASCENT study suggests Trodelvy improves health-related quality of life (HRQoL) compared to single-agent chemotherapy. Gilead aims to expand Trodelvy's potential across various advanced solid tumors. The press release underscores Gilead's commitment to addressing high unmet medical needs in oncology.
Gilead Sciences (Nasdaq: GILD) announced its participation in the Morgan Stanley Annual Global Healthcare Conference on
Gilead Sciences (Nasdaq: GILD) announced the full validation of its Marketing Authorization Application (MAA) for lenacapavir, an investigational HIV-1 capsid inhibitor, by the European Medicines Agency (EMA). This application targets treatment for adults with multidrug resistant HIV-1 infection who are on a failing regimen. The EMA’s Committee for Medicinal Products for Human Use will assess the application. Lenacapavir showed promising results in the CAPELLA study, with 88% of participants achieving significant viral load reduction. It remains investigational and is not yet approved.
Kite, a Gilead Company (Nasdaq: GILD), has partnered with Appia Bio to develop engineered allogeneic cell therapies for hematological malignancies. The collaboration focuses on creating chimeric antigen receptor (CAR)-engineered invariant natural killer T (CAR-iNKT) cells using Appia Bio’s ACUA technology. Appia Bio will lead preclinical and early clinical research, while Kite will oversee development and commercialization. The agreement includes an upfront payment, equity investment, and up to $875 million in milestone payments, signaling a strong commitment to advancing innovative cancer therapies.
BioNTech SE (BNTX) has completed the acquisition of Kite's solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing assets in Gaithersburg, MD. This strategic move enhances BioNTech's cell therapy pipeline and manufacturing capabilities in North America, following its acquisition of Neon Therapeutics in 2020. The deal, which was announced on July 19, 2021, aligns with BioNTech’s strategy of accelerating development through targeted acquisitions. All Kite employees at the facility were offered jobs with BioNTech, ensuring operational continuity.
Gilead Sciences (Nasdaq: GILD) has announced a significant endowment exceeding $200 million to the Gilead Foundation, reinforcing its commitment to enhancing community health globally. Established in 2005, the foundation will focus on health justice, supporting underserved communities, including people of color and LGBTQ+ youth. Key programs include the Creating Possible Fund for grants, charitable donations to local organizations, and an employee donation matching program, increasing annual matches to $15,000. In 2020, Gilead donated $409 million globally for various community needs, including COVID-19 relief.