Gilead Sciences Inc Stock Price, News & Analysis

Marcus, a 36-year-old military veteran, was diagnosed with diffuse large B-cell lymphoma after noticing unusual growths. Although he achieved remission following six rounds of chemotherapy, the cancer returned aggressively, affecting his trigeminal nerve.

He was then referred to the University of Maryland Greenebaum Comprehensive Cancer Center, where he received CAR T-cell therapy. The initial PET CT scan revealed a dramatic response to the treatment. Grateful for the opportunity to spend precious time with his son, Marcus emphasized the importance of life and family.

Kite Pharma, a Gilead Company, and Daiichi Sankyo announced the transfer of marketing authorization for Yescarta (axicabtagene ciloleucel) in Japan to Gilead Sciences K.K. This follows a revision of their 2017 partnership agreement. Kite will manage sales and promotion activities in Japan post-transfer. The manufacturing facility in California is authorized to produce Yescarta for the Japanese market, with supply expected to start in early 2023. Currently, there are six hospitals in Japan approved to provide this CAR T-cell therapy.

Gilead Sciences (GILD) announced new data from the TROPiCS-02 Phase 3 study of Trodelvy (sacituzumab govitecan-hziy) showing improved efficacy in HR+/HER2- metastatic breast cancer patients. Trodelvy outperformed standard chemotherapy, enhancing progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) across varying Trop-2 expression levels. The FDA has accepted a priority review for Trodelvy in this indication, with a decision expected by February 2023.

Gilead Sciences (GILD) announced the European Commission's authorization of a new low-dose tablet form of Biktarvy for HIV treatment in virologically suppressed children aged two years and older, weighing at least 14 kg. This marks the first pediatric approval for Biktarvy in the EU, addressing a significant unmet need for HIV treatment in children. The decision is based on positive results from a clinical study, showing high rates of virological suppression among participants. Biktarvy combines three antiretroviral drugs into a single tablet and is indicated for use without prior evidence of viral resistance.

Gilead Sciences (GILD) and Arcus Biosciences (RCUS) announced positive results from the fourth interim analysis of the Phase 2 ARC-7 study for first-line metastatic non-small cell lung cancer (NSCLC). The analysis, conducted with a data cutoff on August 31, 2022, included 150 patients and demonstrated that both domvanalimab combinations significantly outperformed zimberelimab monotherapy across multiple efficacy measures, including progression-free survival (PFS). Results will be presented at the ASCO Monthly Plenary Series on December 20, 2022.

Gilead Sciences and Arcus Biosciences announced promising results from the fourth interim analysis of the Phase 2 ARC-7 study for first-line NSCLC patients. The study evaluates the effects of domvanalimab (anti-TIGIT) in combination with zimberelimab (anti-PD-1) versus zimberelimab alone. Results indicate significant clinical benefits across key efficacy measures, including progression-free survival (PFS). No unexpected safety issues were noted. Full results will be presented on December 20, 2022, at the ASCO Monthly Plenary Series.

Gilead Sciences (Nasdaq: GILD) will present at key investor conferences including the Evercore ISI Annual HealthCONx Conference on November 29 at 1:00 PM ET, and the Piper Sandler Healthcare Conference on November 30 at 11:30 AM ET. Additionally, the Nasdaq Investor Conference is scheduled for December 7 at 1:00 PM GMT. Live webcasts can be accessed at investors.gilead.com, with replays available for 30 days.

Gilead has over three decades of experience in biopharmaceutical innovation, focusing on treatments for HIV, hepatitis, and cancer.

Gilead Sciences (NASDAQ: GILD) and Kite will present 30 data presentations, including critical updates on CAR T-cell therapies and investigational treatments at the 64th Annual ASH Meeting (December 10-13). Key highlights include three-year results from ZUMA-5 for indolent non-Hodgkin lymphoma and data on magrolimab's potential in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). This reinforces the efficacy of Gilead's therapies and their commitment to improving patient outcomes in blood cancers.

Gilead Sciences has received FDA approval for Vemlidy (tenofovir alafenamide) as a treatment for chronic hepatitis B in patients aged 12 years and older with compensated liver disease. This new approval builds on the 2016 authorization for adult patients. The decision is based on positive results from a Phase 2 clinical trial, where 21% of treated subjects achieved HBV DNA levels below 20 IU/mL at 24 weeks. Vemlidy offers a once-daily dosing regimen, making it a viable option for pediatric patients. However, it carries a boxed warning for potential severe acute exacerbation of hepatitis B post-treatment.