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. (GILD) is a leading biopharmaceutical company focused on developing innovative therapies for life-threatening diseases. This page provides investors and healthcare professionals with timely updates on the company's latest developments, regulatory milestones, and strategic initiatives.
Access comprehensive coverage of Gilead's press releases and news, including updates on antiviral therapies, oncology research, and clinical trial results. Our curated collection features earnings announcements, partnership details, and progress reports on treatments for HIV, hepatitis, and emerging cancer therapies.
Stay informed about critical developments through verified updates on FDA approvals, research collaborations, and therapeutic advancements. All content is organized chronologically for quick reference, with clear sourcing to ensure transparency.
Bookmark this page for streamlined access to Gilead Sciences' official communications and third-party analysis. Regularly updated to reflect the company's evolving pipeline and market position, this resource supports informed decision-making for stakeholders at all levels.
Gilead Sciences (GILD) and Merck (MRK) have entered a collaboration to co-develop long-acting HIV treatments using Gilead's capsid inhibitor, lenacapavir, and Merck's nucleoside reverse transcriptase translocation inhibitor, islatravir. Both compounds are in late-stage clinical trials. The agreement involves equal sharing of global product revenues after certain sales thresholds, with Gilead leading U.S. marketing for oral formulations and Merck for injectables. This partnership aims to address the need for innovative, less frequent dosing options for HIV patients.
Gilead Sciences (Nasdaq: GILD) presented new results from the Phase 2/3 CAPELLA trial for lenacapavir, an investigational long-acting HIV-1 capsid inhibitor. The findings indicate that 73% of participants achieved an undetectable viral load after 26 weeks. This study targets heavily treatment-experienced individuals with multi-drug resistant HIV-1. If approved, lenacapavir could be the first capsid inhibitor available for HIV treatment. The drug aims to provide an innovative long-acting treatment option, highlighting the unmet medical needs in this population.
Gilead Sciences (Nasdaq: GILD) presented long-term data from two Phase 3 studies on Biktarvy for HIV-1 treatment, showing over 98% of participants achieved an undetectable viral load after four years. This data, shared at the virtual CROI 2021, highlights Biktarvy's strong efficacy and safety, with no reported treatment-emergent resistance. Further analysis from the studies showed comparable suppression levels among participants with transmitted drug resistance. Gilead emphasizes its commitment to innovative HIV treatments, aiming to meet patient needs for long-term viral control.
Kite, a Gilead Company (Nasdaq: GILD), has received accelerated approval from the FDA for Yescarta (axicabtagene ciloleucel) to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of therapy. This marks Yescarta as the first CAR T-cell therapy approved for this indication. The approval is based on the ZUMA-5 trial, where 91% of patients responded to treatment, with 74% in remission after 18 months. However, the approval comes with a boxed warning for risks such as cytokine release syndrome (CRS) and neurologic toxicities, requiring a risk evaluation plan.
Gilead Sciences has successfully completed its acquisition of MYR GmbH for approximately €1.45 billion. This strategic move enhances Gilead's portfolio with Hepcludex® (bulevirtide), a treatment for chronic hepatitis delta virus (HDV), conditionally approved by the European Medicines Agency in July 2020. Gilead aims to leverage its extensive experience in viral hepatitis to maximize Hepcludex's potential globally. MYR is now a wholly owned subsidiary of Gilead, although Hepcludex's safety and efficacy are still unestablished in markets outside of Europe.
Gilead Sciences (GILD) will present new data at the virtual CROI 2021, from March 6-10, focusing on HIV, HCV, and COVID-19. The company highlights the urgency for advanced antiviral research due to the COVID-19 pandemic's impact on public health and health equity.Key presentations will include findings from the Phase 2/3 CAPELLA trial on lenacapavir for multidrug-resistant HIV, and the safety and efficacy of Veklury for pediatric COVID-19 patients. These advancements reflect Gilead's commitment to addressing critical health challenges worldwide.
Gilead Sciences (Nasdaq: GILD) announced its executives will participate in two upcoming investor conferences. The SVB Leerink Global Healthcare Conference is scheduled for February 25, 2021, at 1:40 p.m. EST, followed by the Cowen Annual Health Care Conference on March 4, 2021, at 12:10 p.m. EST. Live webcasts of these presentations can be accessed on the company’s investor page, with replays available for at least 14 days post-event.
Gilead is committed to advancing innovative therapies for serious diseases and operates in over 35 countries.
Gilead Sciences (Nasdaq: GILD) has partnered with Wake Forest University School of Divinity as part of its COMPASS Initiative, aimed at addressing the HIV epidemic in the Southern United States. This partnership will expand outreach to faith-based communities, particularly the Black church. Established in 2017, COMPASS is a 10-year initiative investing over $100 million in combating healthcare disparities and HIV stigma. Gilead has provided $52 million to nearly 150 organizations since the program's inception, focusing on areas identified by the CDC as severely impacted by HIV.
Kite, a Gilead Company (Nasdaq: GILD), presented new analysis from the ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) for relapsed or refractory large B-cell lymphoma at the ASTCT meetings. In Cohort 6, prophylactic corticosteroids were used with no Grade ≥3 cytokine release syndrome (CRS) and 13% experienced Grade ≥3 neurologic events. A significant 95% response rate was observed, with 80% achieving complete responses. Early intervention showed promise in managing severe side effects associated with CAR T-cell therapy, emphasizing safety improvements for future applications.
Galapagos NV and Gilead Sciences have announced the halt of the ISABELA Phase 3 clinical studies for ziritaxestat, an investigational autotaxin inhibitor for idiopathic pulmonary fibrosis (IPF). This decision follows the Independent Data Monitoring Committee's review, which indicated that the benefit-risk profile of ziritaxestat no longer supports ongoing trials. The ISABELA program aimed to enroll 1,500 patients, but all trials, including a Phase 2a extension, will be discontinued. Both companies expressed disappointment but remain committed to advancing IPF research.
