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 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.
Gilead Sciences reported a strong Q2 2022, with total revenue rising 1% to $6.3 billion. Noteworthy product sales include Biktarvy, which surged 28% year-over-year to $2.6 billion, and oncology sales, which grew 71% to $527 million. However, diluted EPS decreased to $0.91 from $1.21 due to higher IPR&D expenses from an upfront payment of $300 million. Gilead's updated full-year guidance anticipates total product sales between $24.5 billion and $25.0 billion, and non-GAAP EPS between $6.35 and $6.75.
Gilead Sciences (GILD) has announced positive interim results from the ALLIANCE trial, showing that Biktarvy is effective for HIV patients with HBV coinfection. The trial demonstrated superior suppression of HBV DNA with Biktarvy compared to an alternative regimen. Additionally, data from five years of two Phase 3 studies revealed no treatment failures due to resistance. Overall, 99% of participants maintained an undetectable viral load. These findings highlight Biktarvy's potential as a long-term treatment option for individuals with HIV.
AlloVir (ALVR) announced a registered direct offering to sell 27,458,095 shares at $4.61 each, raising approximately $126.6 million, expected to close around July 28, 2022. The proceeds will fund ongoing Phase 3 trials for posoleucel, aimed at treating severe infections in immunocompromised patients. AlloVir plans to use the funds for trial completion, regulatory submissions, and R&D. As of June 30, 2022, the company had $172.7 million in cash. The offering is made without an underwriter and involves participation from new and existing investors, including Kite (GILD).
Kite, a Gilead Company (GILD), received a positive opinion from the European Medicines Agency (EMA) for Tecartus (brexucabtagene autoleucel) to treat adults over 26 with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This CAR T-cell therapy could address the significant unmet need in this patient population, where median overall survival is approximately eight months. The European Commission will review the opinion, with a decision expected soon. In clinical trials, Tecartus showed a 71% complete remission rate and a median overall survival of over two years for treated patients.
Gilead Sciences (GILD) announced that the European Commission's Committee for Medicinal Products for Human Use (CHMP) has recommended granting full Marketing Authorization for Veklury (remdesivir) in the EU. Initially authorized in July 2020 for COVID-19 treatment in hospitalized patients, the approval expands its use to non-hospitalized adults at risk for severe COVID-19. Veklury remains the only direct-acting antiviral with this full authorization in the EU. The decision is based on robust data confirming Veklury's efficacy against SARS-CoV-2 variants.