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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.
Access comprehensive coverage of Gilead's press releases and news, including updates on antiviral therapies, oncology research, and clinical trial results. Our curated collection features earnings announcements, partnership details, and progress reports on treatments for HIV, hepatitis, and emerging cancer therapies.
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Kite, a Gilead Company, announced a positive opinion from the European Medicines Agency for Yescarta, a CAR T-cell therapy, for adults with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months post-first-line chemoimmunotherapy. The ZUMA-7 study showed a four-fold improvement in event-free survival at two years (41% for Yescarta vs. 16% for standard care). The final decision from the European Commission is expected soon, potentially transforming treatment for these aggressive lymphomas.
Gilead Sciences announced a positive opinion from the European Medicines Agency (EMA) regarding its COVID-19 treatment, Veklury (remdesivir), for pediatric patients under 12 years. If approved by the European Commission, Veklury would be the only authorized antiviral treatment for this demographic, specifically for children at risk of severe COVID-19 or with pneumonia requiring oxygen. The decision is based on positive results from the ongoing CARAVAN Phase 2/3 study, which showed clinical improvement in 75-85% of pediatric participants.
Gilead Sciences announced that the World Health Organization (WHO) has updated its guidelines to include a conditional recommendation for Veklury (remdesivir) in treating both severe and non-severe COVID-19 patients at high risk of hospitalization. The decision stems from the SOLIDARITY study, demonstrating a 17% reduction in the risk of death or progression to ventilation in patients requiring supplemental oxygen. Over 11 million patients globally have received Veklury.
Gilead Sciences announces a $20 million commitment through its Creating Possible Fund to support 13 U.S. organizations focused on education and health equity. This initiative aims to build a pipeline of Black health leaders and enhance educational opportunities for underserved students. Recognizing the interconnectedness of education and health disparities, the fund will finance innovative projects that improve learning environments and social support systems. Gilead's ongoing dedication to health equity is underscored by its collaboration with local communities and organizations.
Gilead Sciences announced positive results from the Phase 3 TROPiCS-02 study, showing Trodelvy improved overall survival by 3.2 months in patients with HR+/HER2- metastatic breast cancer who had received prior therapies. Median overall survival was 14.4 months for Trodelvy compared to 11.2 months for chemotherapy. The results, highlighting Trodelvy's potential in both pre-treated HR+/HER2- and triple-negative breast cancers, will be presented at the ESMO Congress 2022. Gilead has submitted a supplemental Biologics License Application to the FDA for Trodelvy's use in HR+/HER2- metastatic breast cancer.
Kite, a Gilead Company (GILD), announced the European Commission has approved its CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This approval is significant as it is the first CAR T-cell therapy for this patient population. The ZUMA-3 trial showed a 71% complete remission rate and a median overall survival of over two years. Kite emphasizes Tecartus addresses a critical unmet medical need for patients with few treatment options.
Gilead Sciences has announced findings from the Phase 3 TROPiCS-02 study, demonstrating that Trodelvy (sacituzumab govitecan-hziy) significantly improves progression-free survival (PFS) for patients with HR+/HER2- metastatic breast cancer compared to chemotherapy. The study analyzed patients with HER2-low and IHC0 statuses, showing a median PFS of 6.4 months for Trodelvy versus 4.2 months for comparator therapy in HER2-low patients. The company has submitted a supplemental Biologics License Application to the FDA for Trodelvy's use in this indication.
Gilead Sciences (Nasdaq: GILD) announced its participation in three upcoming investor conferences. The Wells Fargo Healthcare Conference will take place on September 8 at 10:25 AM ET, followed by the Morgan Stanley Annual Global Healthcare Conference on September 13 at 10:35 AM ET, and the Baird Global Healthcare Conference on September 14 at 9:40 AM ET. Live webcasts will be available on the investors.gilead.com page, with replays accessible for 30 days.
Gilead Sciences (GILD) announced new data at the ESMO Congress 2022, showcasing the Phase 3 TROPiCS-02 study results for Trodelvy® in HR+/HER2- metastatic breast cancer. The study demonstrated significant overall survival benefits for patients pre-treated with endocrine therapies. Gilead has submitted a supplemental Biologics License Application to the FDA for Trodelvy based on these findings, which highlight the drug's potential against a challenging patient population. Additional presentations included health-related quality of life data and efficacy analyses by HER2 status.
Gilead Sciences announced the European Commission has granted marketing authorization for Sunlenca (lenacapavir), a new HIV treatment for patients with multidrug-resistant strains. This first-in-class medication offers an innovative, long-acting option administered bi-annually, addressing a critical unmet need. In the CAPELLA study, 83% of participants achieved an undetectable viral load at Week 52. This approval follows the FDA's consideration of lenacapavir, with a PDUFA action date set for December 27, 2022, signaling a promising future for treatment options in the evolving HIV landscape.
