Welcome to our dedicated page for Gilead Sciences news (Ticker: GILD), a resource for investors and traders seeking the latest updates and insights on Gilead Sciences stock.
Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
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.
Kite, a Gilead Company (Nasdaq: GILD), has signed a worldwide license agreement with Refuge Biotechnologies for exclusive rights to its gene expression platform aimed at developing treatments for blood cancers. This partnership seeks to enhance CAR T-cell therapies' efficacy and safety through innovative gene regulation. Kite will assume all costs related to research and commercialization and will make an upfront payment to Refuge, which may also receive milestone payments based on performance. Kite aims to broaden patient access to CAR T therapies with this collaboration.
Gilead Sciences (GILD) announced new data on its HIV treatments to be presented at the 30th International Congress on Drug Therapy in HIV Infection from October 23-26, 2022. Key findings include:
- Long-term efficacy of Biktarvy in treatment-naïve and treatment-experienced patients.
- Insights from the BICSTaR study supporting Biktarvy's safety and effectiveness.
- New results on lenacapavir, highlighting its efficacy among multi-drug resistant HIV patients.
These presentations reflect Gilead's commitment to addressing the evolving needs of HIV-affected individuals.
Gilead Sciences (Nasdaq: GILD) announced that the European Commission approved Yescarta for adult patients with diffuse large B-cell lymphoma (DLBCL) who relapse or are refractory after first-line treatment. The approval stems from the pivotal ZUMA-7 study, showing Yescarta provides an event-free survival (EFS) of 8.3 months compared to just 2.0 months with standard care, marking a four-fold improvement. Additionally, Yescarta patients showed a 2.5 fold increase in survival without cancer progression at two years (41% vs. 16%).