Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (GILD) presented new data from the Phase 3 ASCENT study on Trodelvy (sacituzumab govitecan) in Black patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC). The study showed a 56% reduction in the risk of disease worsening or death, with a median progression-free survival (PFS) of 5.4 months versus 2.2 months for chemotherapy. Overall survival also improved to 13.8 months compared to 8.5 months for chemotherapy. Trodelvy demonstrated a higher overall response rate of 32% compared to 6% for chemotherapy. Safety profiles were consistent with earlier findings.

Gilead Sciences has selected AWS as its preferred cloud provider to enhance its clinical trial design and data-driven decision-making capabilities. This collaboration will leverage AWS's machine learning and analytics to refine Gilead's drug pipeline while ensuring patient privacy and data security. Gilead will also implement SAP S/4HANA for its enterprise resource planning, aiming for increased operational efficiency. Additionally, over 50% of its data center footprint will be migrated to AWS, which supports IT transformation and improved disaster recovery processes.

Gilead Sciences (NASDAQ: GILD) will present new data from the Phase 3 ASCENT study of Trodelvy at the San Antonio Breast Cancer Symposium (December 7-10). The analyses focus on treatment outcomes for Black patients with metastatic triple-negative breast cancer (TNBC) and post-progression therapy outcomes. Trodelvy is indicated for patients with metastatic TNBC who have received prior systemic therapies. The study highlights Trodelvy's potential in addressing high unmet needs in cancer care.

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.