Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences announced positive updates from its magrolimab Phase 1b trial for acute myeloid leukemia (AML) patients ineligible for intensive chemotherapy. The combination of magrolimab and azacitidine showed an overall response rate of 63% and 69% for TP53-mutant patients. Complete remission rates were 42% overall and 45% in TP53-mutant patients. Median duration of response was 9.6 months for evaluable patients, and preliminary overall survival was 18.9 months for wild-type and 12.9 months for mutant patients. Adverse events were mostly manageable.

Kite, a Gilead Company (Nasdaq: GILD), announced positive results from the ZUMA-5 Phase 2 study of Yescarta for treating relapsed/refractory indolent non-Hodgkin lymphoma. In evaluable patients, 92% achieved a response, with 76% complete responses at 17.5 months median follow-up. The FDA has accepted a supplemental Biologics License Application for Yescarta, granting it Priority Review for follicular and marginal zone lymphomas, with a target action date of March 5, 2021. The study highlights Yescarta's potential for patients who have limited treatment options in this setting.

Kite, a Gilead Company (Nasdaq: GILD), presented four-year follow-up data from the ZUMA-1 trial for Yescarta® (axicabtagene ciloleucel) at the ASH Annual Meeting. This data indicates a four-year overall survival (OS) rate of 44% among 101 patients with refractory large B-cell lymphoma (LBCL) after a single infusion. No Yescarta-related secondary malignancies were reported. Notably, 67% of patients exhibited detectable CAR gene-marked cells, suggesting potential for durable remissions. Yescarta remains FDA-approved for adult patients with LBCL following two or more systemic therapy lines.

Kite, a Gilead Company (Nasdaq: GILD), reported promising follow-up results from the ZUMA-2 trial for Tecartus™ in adults with relapsed or refractory mantle cell lymphoma (MCL). With a median follow-up of 17.5 months, 92% of 60 evaluable patients responded, including 67% achieving a complete response. Secondary endpoints like progression-free and overall survival were not yet reached. Tecartus received FDA accelerated approval in July, yet continued approval depends on confirming clinical benefits in future trials. Significant adverse effects were noted, including cytokine release syndrome and neurological events.

Gilead Sciences (Nasdaq: GILD) has announced that Johanna Mercier, Chief Commercial Officer, and Merdad Parsey, MD, PhD, Chief Medical Officer, will participate in a fireside chat at the 3rd Annual Evercore ISI HealthCONx Conference. The event is scheduled for Wednesday, December 2 at 11:20 a.m. Eastern Time. Investors can access the live webcast through Gilead's investor page. A replay will be available for 14 days post-event. Gilead Sciences focuses on developing innovative medicines for life-threatening illnesses and operates in over 35 countries.

Gilead Sciences (Nasdaq: GILD) announced positive topline results from the Phase 2/3 CAPELLA trial for lenacapavir, an investigational HIV-1 capsid inhibitor. In this study, 88% of participants on lenacapavir experienced a significant reduction in viral load compared to 17% on placebo, indicating its potential as a treatment for multidrug-resistant HIV-1. Lenacapavir, administered every six months, may become the first HIV capsid inhibitor if approved. The study showed lenacapavir was safe with no serious adverse events reported, supporting further development and regulatory submission.

Gilead Sciences (NASDAQ: GILD) and Novo Nordisk A/S have announced results from a Phase 2 trial assessing the combination of semaglutide and Gilead's investigational drugs cilofexor and firsocostat for treating non-alcoholic steatohepatitis (NASH). Conducted over 24 weeks, the trial included 108 participants and met its primary endpoint, demonstrating tolerability across all regimens. Key improvements in liver health biomarkers were noted, although statistical significance was not achieved for all outcomes. Both companies are now evaluating next steps based on the data presented.

Gilead and Kite announced that 16 abstracts, including three oral presentations, were accepted for the 62nd ASH Annual Meeting, occurring virtually from December 5-8, 2020. Key data on CAR T therapies Yescarta and Tecartus, along with the anti-CD47 monoclonal antibody magrolimab, will be presented. Notably, Yescarta's pivotal ZUMA-1 trial showed promising four-year overall survival results in refractory large B-cell lymphoma. Additionally, magrolimab has received FDA Breakthrough Designation for treating acute myeloid leukemia and myelodysplastic syndromes.

Gilead Sciences (Nasdaq: GILD) and Galapagos NV have announced the validation of their application to the European Medicines Agency (EMA) for a new indication of filgotinib (200 mg) for treating moderately to severely active ulcerative colitis (UC). This application is based on positive results from the Phase 2b/3 SELECTION study, which demonstrated significantly improved clinical remission rates compared to placebo. Filgotinib is already approved in the EU for rheumatoid arthritis and is under investigation for UC, with no global approval yet.