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.
FDA Approves Update for Yescarta: Gilead's Kite has received FDA approval for an update to the prescribing information of Yescarta (axicabtagene ciloleucel). This update allows for the use of prophylactic corticosteroids across all approved indications, marking Yescarta as the first CAR T-cell therapy with guidelines for managing treatment-related side effects. The update is based on a safety management cohort from the ZUMA-1 study, showing a significant reduction in severe cytokine release syndrome (CRS) events compared to prior cohorts.
Gilead Sciences (Nasdaq: GILD) has announced a partial clinical hold on studies evaluating the combination of magrolimab and azacitidine due to suspected unexpected serious adverse reactions (SUSARs). This hold will pause new patient enrollment in the affected studies while current participants can continue receiving treatment. Other magrolimab studies remain unaffected. Gilead is collaborating with regulatory authorities to determine next steps and emphasizes patient safety as a priority.
Gilead Sciences announced the FDA's expedited approval of Veklury (remdesivir) for non-hospitalized adults and adolescents at high risk of severe COVID-19. The approval allows outpatient administration over three days and expands the pediatric EUA to include children under 12. Veklury showed an 87% reduction in hospitalization risk in clinical trials. This development comes amid rising COVID-19 cases and variants' impact on treatment options.
Gilead is committed to ensuring availability in outpatient settings while maintaining supply for hospitalized patients.
Gilead Sciences, Inc. (NASDAQ: GILD) announced that it will release its fourth quarter and full year 2021 financial results on February 1, after market close. Management will discuss these results in a live webcast at 4:30 PM ET on the same day. Investors can access the webcast through Gilead's investor relations page and it will be archived for one year. Gilead has been a leader in biopharmaceuticals for over three decades, focusing on innovative treatments for serious diseases such as HIV, hepatitis, and cancer.
Gilead Sciences (NASDAQ: GILD) announced collaborations with Merck to evaluate Trodelvy in combination with KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer (NSCLC). Merck will sponsor a global Phase 3 trial, while Gilead will conduct a Phase 2 study. NSCLC, as the leading lung cancer type, presents a significant unmet medical need due to a low five-year survival rate of 25%. Trodelvy, currently approved for certain cancers, is under investigation for this new indication, and the safety and efficacy for NSCLC treatment remain unestablished.
Gilead Sciences (GILD) announced positive results from a Phase 3 study of Veklury (remdesivir) for treating COVID-19 in non-hospitalized patients at high risk of disease progression. The study reported an 87% reduction in hospitalization or death risk and an 81% reduction in medical visits compared to placebo. Subgroup analyses showed consistent efficacy for patients with comorbidities. Although investigational, these findings are submitted to the FDA for approval, emphasizing Veklury's crucial role in outpatient care.
Gilead Sciences announced a clinical hold imposed by the FDA on injectable lenacapavir for HIV treatment and PrEP due to compatibility issues with borosilicate vials. This hold affects ongoing studies, preventing enrollment and dosing of injectable lenacapavir. However, oral lenacapavir formulations remain unaffected. Gilead is committed to resolving the vial quality issue promptly, noting that lenacapavir is still under investigation and not yet approved. The company emphasized its dedication to addressing this challenge and advancing research on HIV treatments.
Gilead Sciences (GILD) and Arcus Biosciences (RCUS) confirmed the closure of Gilead's option exercises on three of Arcus’ clinical-stage programs, including domvanalimab, AB308, etrumadenant, and quemliclustat, as of November 17, 2021. This transaction, following the expiration of antitrust waiting periods, entitles Arcus to receive $725 million from Gilead. Future collaboration includes co-development and profit-sharing in the U.S., along with tiered royalties on international sales. The collaboration supports advancements in cancer treatment through innovative drug candidates.
Gilead Sciences (GILD) and Arcus Biosciences (RCUS) announced the closing of Gilead's option exercises for three clinical-stage programs in Arcus's portfolio, including anti-TIGIT molecules and other candidates. This agreement results in option payments of $725 million from Gilead to Arcus, expected in early Q1 2022. Under the collaboration, Gilead and Arcus will co-develop the programs and share costs, with Gilead holding exclusive commercialization rights outside the U.S. The transaction followed the expiration of the Hart-Scott-Rodino waiting period.
Gilead Sciences (Nasdaq: GILD) announced its participation in the J.P. Morgan Healthcare Conference on Monday, January 10, starting at 11:15 a.m. Eastern Time. Executives will present and engage in a Q&A breakout session.
The live webcast will be available at investors.gilead.com, with replays accessible for at least 30 days post-event.
Gilead is a biopharmaceutical leader focusing on innovative treatments for serious diseases, operating in over 35 countries.
