Gilead Sciences Inc Stock Price, News & Analysis

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.

Gilead Sciences (NASDAQ: GILD) will present over 70 clinical and real-world abstracts at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting from Nov. 4-8, 2022. Key highlights include analyses from studies on Hepcludex (bulevirtide) for chronic hepatitis delta virus and an investigational HBV vaccine. Findings show Hepcludex's safety and efficacy and explore new treatment strategies for chronic hepatitis B and C. Gilead emphasizes its commitment to addressing unmet liver disease needs.

Gilead Sciences reported a 5% decline in total revenue to $7.0 billion for Q3 2022, primarily due to falling sales of Veklury®, offset by increases in HIV and oncology products. Notably, sales of Biktarvy® rose 22% to $2.8 billion, and oncology sales surged 79% to $578 million. EPS decreased to $1.42 from $2.05 in 2021. Gilead adjusted its full-year guidance to anticipate $25.9-$26.2 billion in total product sales, up from earlier estimates. The company also generated $2.9 billion in operating cash flow while repaying $1.0 billion in debt.

Gilead Sciences presented new data from the BICSTaR study on its HIV treatment Biktarvy at the 30th International Congress on Drug Therapy in HIV Infection. The results show that after 24 months, 97% of treatment-naïve and 95% of treatment-experienced participants achieved viral suppression. Additionally, over 99% of participants remained suppressed at 240 weeks in follow-up studies, demonstrating the long-term efficacy and safety of Biktarvy. The FDA has updated Biktarvy's label to include data from these trials.