Welcome to our dedicated page for Gilead Sciences news (Ticker: GILD), a resource for investors and traders seeking the latest updates and insights on Gilead Sciences stock.
Gilead Sciences, Inc. (Nasdaq: GILD) is a biopharmaceutical company focused on medicines for HIV, viral hepatitis, COVID‑19, cancer and inflammation. The GILD news feed highlights how the company’s research, collaborations and policy decisions translate into clinical programs, regulatory milestones and access initiatives across these therapeutic areas.
Investors and healthcare observers following GILD news will see regular updates on Gilead’s HIV portfolio, including clinical trial readouts such as the Phase 3 ARTISTRY‑1 and ARTISTRY‑2 studies of an investigational single‑tablet regimen combining bictegravir and lenacapavir for virologically suppressed adults with HIV. News also covers developments related to lenacapavir as a long‑acting option for HIV prevention and treatment, as well as agreements affecting key products like Biktarvy, including patent settlements disclosed by the company.
Oncology and cell therapy news is another major theme. Through Kite, a Gilead company, GILD‑related releases feature data on Yescarta for relapsed or refractory large B‑cell lymphoma, next‑generation bicistronic CAR T‑cell candidates KITE‑753 and KITE‑363 for B‑cell lymphomas, and anitocabtagene autoleucel (anito‑cel) for relapsed or refractory multiple myeloma. Updates often include efficacy and safety results from pivotal and early‑stage trials, as well as details on collaborations such as the partnership with Arcellx on anito‑cel and the research collaboration with OncoNano Medicine on ON‑BOARD encapsulation technology.
Gilead news also reflects broader corporate and policy activity, including agreements with the U.S. government related to drug pricing and access, philanthropic grants from the Gilead Foundation for metastatic breast cancer support, leadership appointments, investor conference presentations and quarterly financial announcements. Bookmark this page to monitor how these scientific, commercial, governance and access‑related developments shape the ongoing story of GILD.
Kite, a Gilead Company (Nasdaq: GILD), announced positive results from the ZUMA-5 Phase 2 study of Yescarta for treating relapsed/refractory indolent non-Hodgkin lymphoma. In evaluable patients, 92% achieved a response, with 76% complete responses at 17.5 months median follow-up. The FDA has accepted a supplemental Biologics License Application for Yescarta, granting it Priority Review for follicular and marginal zone lymphomas, with a target action date of March 5, 2021. The study highlights Yescarta's potential for patients who have limited treatment options in this setting.
Kite, a Gilead Company (Nasdaq: GILD), presented four-year follow-up data from the ZUMA-1 trial for Yescarta® (axicabtagene ciloleucel) at the ASH Annual Meeting. This data indicates a four-year overall survival (OS) rate of 44% among 101 patients with refractory large B-cell lymphoma (LBCL) after a single infusion. No Yescarta-related secondary malignancies were reported. Notably, 67% of patients exhibited detectable CAR gene-marked cells, suggesting potential for durable remissions. Yescarta remains FDA-approved for adult patients with LBCL following two or more systemic therapy lines.
Kite, a Gilead Company (Nasdaq: GILD), reported promising follow-up results from the ZUMA-2 trial for Tecartus™ in adults with relapsed or refractory mantle cell lymphoma (MCL). With a median follow-up of 17.5 months, 92% of 60 evaluable patients responded, including 67% achieving a complete response. Secondary endpoints like progression-free and overall survival were not yet reached. Tecartus received FDA accelerated approval in July, yet continued approval depends on confirming clinical benefits in future trials. Significant adverse effects were noted, including cytokine release syndrome and neurological events.
Gilead Sciences (Nasdaq: GILD) has announced that Johanna Mercier, Chief Commercial Officer, and Merdad Parsey, MD, PhD, Chief Medical Officer, will participate in a fireside chat at the 3rd Annual Evercore ISI HealthCONx Conference. The event is scheduled for Wednesday, December 2 at 11:20 a.m. Eastern Time. Investors can access the live webcast through Gilead's investor page. A replay will be available for 14 days post-event. Gilead Sciences focuses on developing innovative medicines for life-threatening illnesses and operates in over 35 countries.
Gilead Sciences (Nasdaq: GILD) announced positive topline results from the Phase 2/3 CAPELLA trial for lenacapavir, an investigational HIV-1 capsid inhibitor. In this study, 88% of participants on lenacapavir experienced a significant reduction in viral load compared to 17% on placebo, indicating its potential as a treatment for multidrug-resistant HIV-1. Lenacapavir, administered every six months, may become the first HIV capsid inhibitor if approved. The study showed lenacapavir was safe with no serious adverse events reported, supporting further development and regulatory submission.
Gilead Sciences (NASDAQ: GILD) and Novo Nordisk A/S have announced results from a Phase 2 trial assessing the combination of semaglutide and Gilead's investigational drugs cilofexor and firsocostat for treating non-alcoholic steatohepatitis (NASH). Conducted over 24 weeks, the trial included 108 participants and met its primary endpoint, demonstrating tolerability across all regimens. Key improvements in liver health biomarkers were noted, although statistical significance was not achieved for all outcomes. Both companies are now evaluating next steps based on the data presented.
Gilead and Kite announced that 16 abstracts, including three oral presentations, were accepted for the 62nd ASH Annual Meeting, occurring virtually from December 5-8, 2020. Key data on CAR T therapies Yescarta and Tecartus, along with the anti-CD47 monoclonal antibody magrolimab, will be presented. Notably, Yescarta's pivotal ZUMA-1 trial showed promising four-year overall survival results in refractory large B-cell lymphoma. Additionally, magrolimab has received FDA Breakthrough Designation for treating acute myeloid leukemia and myelodysplastic syndromes.
Gilead Sciences (Nasdaq: GILD) and Galapagos NV have announced the validation of their application to the European Medicines Agency (EMA) for a new indication of filgotinib (200 mg) for treating moderately to severely active ulcerative colitis (UC). This application is based on positive results from the Phase 2b/3 SELECTION study, which demonstrated significantly improved clinical remission rates compared to placebo. Filgotinib is already approved in the EU for rheumatoid arthritis and is under investigation for UC, with no global approval yet.
Gilead Sciences, Inc. (Nasdaq: GILD) has declared a cash dividend of $0.68 per share of common stock for Q4 2020. This dividend is payable on December 30, 2020, to stockholders on record by December 15, 2020. The company focuses on the discovery and development of innovative medicines for serious illnesses. Gilead operates in over 35 countries, aiming to enhance patient care worldwide.
Gilead Sciences (Nasdaq: GILD) reported third-quarter 2020 revenues of $6.6 billion, a 17% increase from $5.6 billion in Q3 2019. Product sales rose 18%, attributed mainly to strong demand for HIV products and the COVID-19 treatment, Veklury, which generated $873 million. GAAP net income was $360 million ($0.29 EPS), a turnaround from a net loss in Q3 2019. Non-GAAP net income reached $2.7 billion ($2.11 EPS), reflecting a 27% year-over-year increase. However, HCV product sales significantly declined by 31%. Gilead's updated 2020 revenue guidance reflects the ongoing impact of the COVID-19 pandemic.