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Gilead Sciences (GILD) has announced interim results from the ASSURE study, which show that seladelpar, an investigational PPAR delta agonist, significantly improves liver disease markers and reduces itching in primary biliary cholangitis (PBC) patients. The study enrolled 174 patients, with 70% of those treated for 12 months meeting the composite endpoint, and 37% achieving ALP normalization. Seladelpar also reduced other liver injury markers. No serious adverse events were reported. This data aligns with the Phase 3 RESPONSE study, highlighting seladelpar's potential as a new therapy for PBC. The FDA has accepted a New Drug Application for seladelpar, with a decision expected in August 2024.
Kite, a Gilead Company (Nasdaq: GILD), announced 12 abstracts from its CAR T-cell therapy portfolio at the 2024 European Hematology Association Annual Congress. Key highlights include higher manufacturing success rates and improved T-cell performance for Yescarta in second-line treatments for relapsed/refractory large B-cell lymphoma (R/R LBCL). Preliminary results from the ZUMA-24 study show promising safety and efficacy for outpatient administration of Yescarta. An oral presentation highlighted Phase 1 results and Phase 3 trial design of anitocabtagene autoleucel (anito-cel) for relapsed/refractory multiple myeloma (R/R MM). Kite's progress aims to enhance patient outcomes and CAR T-cell therapy accessibility, with additional studies on cost-effectiveness, safety, and real-world outcomes.
Gilead Sciences has initiated the Native Health Navigator (NHN) program, supported by their Toward Health Equity Oncology Grant. The program aims to connect Native American cancer patients to necessary medical care at CHRISTUS St. Vincent Regional Cancer Center.
Led by Olivia Sloan, a registered nurse, and Shayna Grandbois-Herrera, the program's first navigator, the NHN program assists patients with transportation, childcare, insurance, and even groceries. This initiative aims to reduce late-stage breast cancer diagnoses by providing culturally sensitive support, ultimately improving health outcomes for Native American communities.
Arcellx and Kite, in partnership with Gilead Company, announced updates on their anitocabtagene autoleucel (anito-cel) multiple myeloma program. The global Phase 3 trial, iMMagine-3, will evaluate anito-cel in patients with relapsed and/or refractory multiple myeloma exposed to specific previous treatments. The technical transfer for manufacturing anito-cel is complete, and preliminary data from the iMMagine-1 trial is expected by year-end.
Kite, a Gilead Company, and Arcellx, Inc. announced operational updates on their anito-cel multiple myeloma program. They shared the iMMagine-3 trial design, manufacturing details, and plans to present data from the iMMagine-1 trial. Anito-cel is a BCMA CAR T cell therapy for relapsed/refractory multiple myeloma.
Gilead's FOCUS Program, launched in 2010, has been instrumental in early HIV detection and linkage to care. By partnering with state and local officials, healthcare providers, and organizations, the program has significantly reduced late-stage HIV diagnoses in underserved populations across the United States.
Gilead's partnership with the government of Mauritius has helped in the elimination of Hepatitis C in the country. By providing low-cost treatment and working with high-prevalence regions, the company has contributed to the success of patients like James, who is now free from the disease. The government's commitment and public-private partnerships have been instrumental in the progress towards eradicating Hepatitis C in the region.
Gilead Sciences, Inc. and Kite, a Gilead Company, will present 18 abstracts at the 2024 ASCO Annual Meeting, showcasing their commitment to developing innovative cancer treatments. The data cover a broad range of cancers, including lung, breast, and gastrointestinal, with highlights on Trodelvy in NSCLC, gastrointestinal pipeline progress, and new CAR T-cell therapy data. The company continues to focus on transforming cancer treatment through groundbreaking research.
Forbes has recognized Gilead as one of America's Best Employers for Diversity. The company's commitment to inclusion and diversity is highlighted, reflecting positive feedback from employees and the community. Gilead Sciences, a biopharmaceutical company, aims to innovate medicines for unmet medical needs globally.
Gilead Sciences, Inc. (Nasdaq: GILD) executives will be speaking at several upcoming investor conferences, showcasing the company's commitment to advancing innovative medicines for life-threatening diseases such as HIV, viral hepatitis, COVID-19, and cancer. The live webcasts and replays will be available on the company's investors page. Gilead operates globally with headquarters in Foster City, California.
