Gilead Sciences Inc Stock Price, News & Analysis

The European Commission has granted marketing authorization for Trodelvy (sacituzumab govitecan), developed by Gilead Sciences (GILD), for treating adult patients with metastatic triple-negative breast cancer (TNBC) after two or more therapies. The approval is supported by Phase 3 ASCENT study results, showing a 49% reduction in death risk and improved overall survival (11.8 months vs. 6.9 months). This is a significant treatment option for this aggressive cancer type, which has a five-year survival rate of only 12%. Trodelvy is also approved in several other countries.

Gilead Sciences (GILD) has submitted a Biologics License Application (BLA) for bulevirtide, an investigational treatment for chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. If approved, it will be the first treatment option in the U.S. for this condition. The submission is backed by Phase 2 and 3 study data, showing 36.7% response after 24 weeks with bulevirtide 2 mg. The drug has received Breakthrough Therapy and Orphan Drug designations from the FDA, emphasizing its potential significance in addressing severe liver disease.

Gilead Sciences (Nasdaq: GILD) announced its participation in the Evercore ISI Annual HealthCONx Conference on Thursday, December 2 at 2:40 PM ET. Investors can access a live webcast on the company’s investors page, with a replay available for 30 days post-presentation. Gilead is a biopharmaceutical leader committed to innovative treatments for serious diseases including HIV, viral hepatitis, and cancer, operating in over 35 countries from its headquarters in Foster City, California.

Gilead Sciences has exercised options for three clinical-stage programs from Arcus Biosciences, including anti-TIGIT agents domvanalimab and AB308, as well as etrumadenant and quemliclustat. This move involves $725 million in option payments to Arcus. The companies are set to co-develop these candidates, share global costs, and explore innovative treatment combinations. Antitrust clearance is required, with expected closure by year-end.

Gilead Sciences has exercised options for three clinical-stage programs from Arcus Biosciences, including domvanalimab, AB308, etrumadenant, and quemliclustat. The agreement, subject to antitrust clearance, results in Arcus receiving $725 million in option payments. The collaboration aims to accelerate the clinical development of these programs, which target hard-to-treat cancers like lung and pancreatic cancer. Notably, Gilead will pursue novel treatment combinations, enhancing its oncology portfolio.

Gilead Sciences announced that the EVER-132-001 trial of sacituzumab govitecan (Trodelvy) met its primary endpoint with an objective response rate (ORR) of 38.8% in patients with metastatic triple-negative breast cancer (TNBC) who received prior therapies. The trial, conducted in China, included 80 patients and demonstrated consistent results with previous studies. No new safety signals were identified. The company is preparing for a product launch in China, emphasizing the potential impact on treatment for patients with limited options.

Gilead Sciences (Nasdaq: GILD) is presenting over 30 abstracts at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting from November 12-15. The presentations cover various liver diseases, including chronic hepatitis delta virus (HDV), hepatitis C (HCV), and hepatitis B (HBV). Key data includes the impact of bulevirtide on HDV treatment outcomes and global efforts towards HCV elimination. Gilead emphasizes its commitment to addressing unmet needs in liver disease treatment.

Gilead Sciences and Kite will showcase advancements in CAR T-cell therapies at the upcoming ASH Annual Meeting (Dec 11-14). Highlights include over 20 abstracts, with the landmark ZUMA-7 study presenting efficacy and safety results in relapsed/refractory large B-cell lymphoma (LBCL). Kite's research aims to improve treatment standards and patient survival rates. Additionally, new findings on investigational magrolimab will be discussed, indicating significant potential in AML treatments. Gilead emphasizes broad potential across its oncology pipeline amid evolving cancer treatment strategies.

Gilead Sciences (GILD) announced interim results from the BICSTaR study, showcasing Biktarvy's effectiveness in treating HIV across 1,135 patients. After one year, 97% of treatment-naïve and 96% of treatment-experienced participants achieved virologic suppression. High adherence to the medication (91%) was reported, with 13% experiencing adverse events, mostly mild. Biktarvy’s robust efficacy in long-term treatment switch scenarios was also emphasized, with 99% maintaining viral suppression over 101 weeks, reinforcing its role in improving the quality of life for diverse HIV populations.