Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) has announced the validation of its Marketing Authorization Application for sacituzumab govitecan-hziy (SG) by the European Medicines Agency (EMA). This first-in-class therapy targets Trop-2 for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies. The EMA is conducting an accelerated review due to the high unmet medical need in this area. SG has already received FDA approval in the U.S., and similar reviews are ongoing in several countries including the U.K. and Canada.

Gilead Sciences (Nasdaq: GILD) and Novo Nordisk (Nasdaq Copenhagen: NOVO B) have expanded their clinical collaboration to study non-alcoholic steatohepatitis (NASH). They will conduct a Phase 2b trial involving approximately 440 patients to evaluate the safety and efficacy of semaglutide, cilofexor, and firsocostat. The study builds on prior positive results from a Phase 2a trial. NASH is a progressive liver disease with no current approved treatments. Key risks include uncertainties about clinical outcomes and collaboration benefits.

Gilead Sciences (GILD) and Merck (MRK) have entered a collaboration to co-develop long-acting HIV treatments using Gilead's capsid inhibitor, lenacapavir, and Merck's nucleoside reverse transcriptase translocation inhibitor, islatravir. Both compounds are in late-stage clinical trials. The agreement involves equal sharing of global product revenues after certain sales thresholds, with Gilead leading U.S. marketing for oral formulations and Merck for injectables. This partnership aims to address the need for innovative, less frequent dosing options for HIV patients.

Gilead Sciences (Nasdaq: GILD) presented new results from the Phase 2/3 CAPELLA trial for lenacapavir, an investigational long-acting HIV-1 capsid inhibitor. The findings indicate that 73% of participants achieved an undetectable viral load after 26 weeks. This study targets heavily treatment-experienced individuals with multi-drug resistant HIV-1. If approved, lenacapavir could be the first capsid inhibitor available for HIV treatment. The drug aims to provide an innovative long-acting treatment option, highlighting the unmet medical needs in this population.

Gilead Sciences (Nasdaq: GILD) presented long-term data from two Phase 3 studies on Biktarvy for HIV-1 treatment, showing over 98% of participants achieved an undetectable viral load after four years. This data, shared at the virtual CROI 2021, highlights Biktarvy's strong efficacy and safety, with no reported treatment-emergent resistance. Further analysis from the studies showed comparable suppression levels among participants with transmitted drug resistance. Gilead emphasizes its commitment to innovative HIV treatments, aiming to meet patient needs for long-term viral control.

Kite, a Gilead Company (Nasdaq: GILD), has received accelerated approval from the FDA for Yescarta (axicabtagene ciloleucel) to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of therapy. This marks Yescarta as the first CAR T-cell therapy approved for this indication. The approval is based on the ZUMA-5 trial, where 91% of patients responded to treatment, with 74% in remission after 18 months. However, the approval comes with a boxed warning for risks such as cytokine release syndrome (CRS) and neurologic toxicities, requiring a risk evaluation plan.

Gilead Sciences has successfully completed its acquisition of MYR GmbH for approximately €1.45 billion. This strategic move enhances Gilead's portfolio with Hepcludex® (bulevirtide), a treatment for chronic hepatitis delta virus (HDV), conditionally approved by the European Medicines Agency in July 2020. Gilead aims to leverage its extensive experience in viral hepatitis to maximize Hepcludex's potential globally. MYR is now a wholly owned subsidiary of Gilead, although Hepcludex's safety and efficacy are still unestablished in markets outside of Europe.

Gilead Sciences (GILD) will present new data at the virtual CROI 2021, from March 6-10, focusing on HIV, HCV, and COVID-19. The company highlights the urgency for advanced antiviral research due to the COVID-19 pandemic's impact on public health and health equity.Key presentations will include findings from the Phase 2/3 CAPELLA trial on lenacapavir for multidrug-resistant HIV, and the safety and efficacy of Veklury for pediatric COVID-19 patients. These advancements reflect Gilead's commitment to addressing critical health challenges worldwide.

Gilead Sciences (Nasdaq: GILD) announced its executives will participate in two upcoming investor conferences. The SVB Leerink Global Healthcare Conference is scheduled for February 25, 2021, at 1:40 p.m. EST, followed by the Cowen Annual Health Care Conference on March 4, 2021, at 12:10 p.m. EST. Live webcasts of these presentations can be accessed on the company’s investor page, with replays available for at least 14 days post-event.

Gilead is committed to advancing innovative therapies for serious diseases and operates in over 35 countries.