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.
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.
Gilead Sciences announced a $4.5 million funding initiative aimed at improving health outcomes for Black Americans in the Southern United States. This collaboration with the Satcher Health Leadership Institute and Xavier University focuses on addressing inequities in HIV care. The funds will support efforts in Atlanta, Baton Rouge, and New Orleans over three years, enhancing access to culturally appropriate care, training, and understanding COVID-19's impact on healthcare delivery. This initiative aligns with Gilead's broader strategy to advance health equity.
Gilead Sciences has announced an agreement with Everest Medicines to acquire development and commercialization rights for Trodelvy (sacituzumab govitecan) in multiple Asian markets, including Greater China and South Korea. The deal involves a $280 million upfront payment and potential additional payments totaling $175 million based on regulatory standards. Trodelvy is already approved for adult patients with certain types of metastatic breast cancer and ongoing regulatory applications in several regions. This acquisition enhances Gilead's oncology portfolio and aims to expand patient access to Trodelvy.
Gilead Sciences announced significant findings from the second interim analysis of the TROPiCS-02 study, demonstrating Trodelvy's potential to improve overall survival in HR+/HER2- metastatic breast cancer patients who received previous treatments. This analysis showed clinically meaningful results, with safety profiles consistent with prior studies. Gilead has submitted a supplemental Biologics License Application to the FDA for this indication. Trodelvy, though not yet approved for this specific use, is already recognized for treating other cancer types.
Gilead Sciences (Nasdaq: GILD) has announced its acquisition of MiroBio, a UK-based biotechnology company, for approximately $405 million in cash. This strategic move provides Gilead with MiroBio's proprietary discovery platform and its pipeline of immune checkpoint agonists aimed at treating autoimmune diseases. Notably, MiroBio's lead investigational antibody, MB272, which targets immune inhibitory receptors, has entered Phase 1 clinical trials. The acquisition is expected to reduce Gilead's 2022 EPS by $0.30-$0.35.