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.
ImmunoGen (Nasdaq: IMGN) has announced a clinical collaboration with Gilead Sciences (Nasdaq: GILD) to investigate the safety and anti-leukemia activity of pivekimab sunirine combined with magrolimab in patients with relapsed CD123-positive acute myeloid leukemia (AML). This partnership aims to explore the complementary mechanisms of action of both drugs. The new cohort, part of ImmunoGen's ongoing 802 study, will evaluate up to 42 patients with a focus on the complete response rate. Pivekimab is being developed for various hematologic malignancies and has received critical designations from regulatory bodies.
Marcus, a 36-year-old military veteran, was diagnosed with diffuse large B-cell lymphoma after noticing unusual growths. Although he achieved remission following six rounds of chemotherapy, the cancer returned aggressively, affecting his trigeminal nerve.
He was then referred to the University of Maryland Greenebaum Comprehensive Cancer Center, where he received CAR T-cell therapy. The initial PET CT scan revealed a dramatic response to the treatment. Grateful for the opportunity to spend precious time with his son, Marcus emphasized the importance of life and family.
Kite Pharma, a Gilead Company, and Daiichi Sankyo announced the transfer of marketing authorization for Yescarta (axicabtagene ciloleucel) in Japan to Gilead Sciences K.K. This follows a revision of their 2017 partnership agreement. Kite will manage sales and promotion activities in Japan post-transfer. The manufacturing facility in California is authorized to produce Yescarta for the Japanese market, with supply expected to start in early 2023. Currently, there are six hospitals in Japan approved to provide this CAR T-cell therapy.
Gilead Sciences (GILD) announced new data from the TROPiCS-02 Phase 3 study of Trodelvy (sacituzumab govitecan-hziy) showing improved efficacy in HR+/HER2- metastatic breast cancer patients. Trodelvy outperformed standard chemotherapy, enhancing progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) across varying Trop-2 expression levels. The FDA has accepted a priority review for Trodelvy in this indication, with a decision expected by February 2023.
Gilead Sciences (GILD) announced the European Commission's authorization of a new low-dose tablet form of Biktarvy for HIV treatment in virologically suppressed children aged two years and older, weighing at least 14 kg. This marks the first pediatric approval for Biktarvy in the EU, addressing a significant unmet need for HIV treatment in children. The decision is based on positive results from a clinical study, showing high rates of virological suppression among participants. Biktarvy combines three antiretroviral drugs into a single tablet and is indicated for use without prior evidence of viral resistance.
Gilead Sciences (GILD) and Arcus Biosciences (RCUS) announced positive results from the fourth interim analysis of the Phase 2 ARC-7 study for first-line metastatic non-small cell lung cancer (NSCLC). The analysis, conducted with a data cutoff on August 31, 2022, included 150 patients and demonstrated that both domvanalimab combinations significantly outperformed zimberelimab monotherapy across multiple efficacy measures, including progression-free survival (PFS). Results will be presented at the ASCO Monthly Plenary Series on December 20, 2022.
Gilead Sciences and Arcus Biosciences announced promising results from the fourth interim analysis of the Phase 2 ARC-7 study for first-line NSCLC patients. The study evaluates the effects of domvanalimab (anti-TIGIT) in combination with zimberelimab (anti-PD-1) versus zimberelimab alone. Results indicate significant clinical benefits across key efficacy measures, including progression-free survival (PFS). No unexpected safety issues were noted. Full results will be presented on December 20, 2022, at the ASCO Monthly Plenary Series.
Gilead Sciences (Nasdaq: GILD) will present at key investor conferences including the Evercore ISI Annual HealthCONx Conference on November 29 at 1:00 PM ET, and the Piper Sandler Healthcare Conference on November 30 at 11:30 AM ET. Additionally, the Nasdaq Investor Conference is scheduled for December 7 at 1:00 PM GMT. Live webcasts can be accessed at investors.gilead.com, with replays available for 30 days.
Gilead has over three decades of experience in biopharmaceutical innovation, focusing on treatments for HIV, hepatitis, and cancer.
Gilead Sciences (NASDAQ: GILD) and Kite will present 30 data presentations, including critical updates on CAR T-cell therapies and investigational treatments at the 64th Annual ASH Meeting (December 10-13). Key highlights include three-year results from ZUMA-5 for indolent non-Hodgkin lymphoma and data on magrolimab's potential in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). This reinforces the efficacy of Gilead's therapies and their commitment to improving patient outcomes in blood cancers.
Gilead Sciences has received FDA approval for Vemlidy (tenofovir alafenamide) as a treatment for chronic hepatitis B in patients aged 12 years and older with compensated liver disease. This new approval builds on the 2016 authorization for adult patients. The decision is based on positive results from a Phase 2 clinical trial, where 21% of treated subjects achieved HBV DNA levels below 20 IU/mL at 24 weeks. Vemlidy offers a once-daily dosing regimen, making it a viable option for pediatric patients. However, it carries a boxed warning for potential severe acute exacerbation of hepatitis B post-treatment.