Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) announced that the FDA granted full approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have undergone two or more systemic therapies. Based on data from the Phase 3 ASCENT study, Trodelvy showed a 57% reduction in disease worsening and extended median progression-free survival (PFS) to 4.8 months, and overall survival (OS) to 11.8 months. Trodelvy may become a standard treatment for this aggressive cancer type.

Kite has submitted a supplemental Biologics License Application (sBLA) for Tecartus (brexucabtagene autoleucel) to the FDA, targeting adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The submission is supported by data from the Phase 1/2 ZUMA-3 trial. Tecartus, previously granted Breakthrough Therapy Designation, could be the first CAR T-cell therapy approved for adult ALL. Survival rates for these patients remain low, underlining the importance of this potential treatment.

Gilead Sciences (Nasdaq: GILD) announced the passing of John C. Martin, PhD, former CEO from 1996-2016 and chairman from 2008-2019. His leadership transformed Gilead, enhancing access to treatments and driving growth. Martin, who joined Gilead in 1990, left a lasting legacy in biopharmaceuticals, impacting millions of patients globally. Current CEO Daniel O’Day expressed deep condolences, highlighting Martin’s significant contributions to scientific advancements. Gilead continues to focus on innovative medicines for serious diseases like HIV, hepatitis, and cancer, operating in over 35 countries worldwide.

Gilead Sciences (Nasdaq: GILD) has appointed Flavius Martin, MD, as Executive Vice President, Research, effective April 12, 2021, following the retirement of Bill Lee, PhD. Dr. Martin, previously associated with Amgen, brings extensive expertise in oncology and inflammation research. Gilead's Chairman and CEO, Daniel O’Day, expressed confidence in Dr. Martin's ability to enhance Gilead’s research portfolio, focusing on unmet medical needs. Bill Lee, who led various therapeutic advancements over 30 years, leaves a strong legacy at Gilead.

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.