Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
Gilead Sciences (GILD) announced that Health Canada has approved Trodelvy (sacituzumab govitecan-hziy) as a second-line treatment for adults with metastatic triple-negative breast cancer (TNBC) who have undergone two or more prior therapies. This approval follows Trodelvy's demonstrated survival benefits in the Phase 3 ASCENT study, showing a 49% reduction in the risk of death. Trodelvy is now authorized in multiple countries, including the U.S., Australia, Great Britain, and Switzerland, under the Project Orbis initiative. Concerns include severe adverse reactions, such as neutropenia and diarrhea.
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 September 15 at 12:30pm ET. The presentation will be available via a live webcast on the company’s investors page, with a replay accessible for 30 days afterward. Gilead is a biopharmaceutical company focused on developing innovative medicines to combat serious diseases like HIV, viral hepatitis, and cancer, operating in over 35 countries.
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.