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, Inc. (Nasdaq: GILD) is a biopharmaceutical company focused on medicines for HIV, viral hepatitis, COVID‑19, cancer and inflammation. The GILD news feed highlights how the company’s research, collaborations and policy decisions translate into clinical programs, regulatory milestones and access initiatives across these therapeutic areas.
Investors and healthcare observers following GILD news will see regular updates on Gilead’s HIV portfolio, including clinical trial readouts such as the Phase 3 ARTISTRY‑1 and ARTISTRY‑2 studies of an investigational single‑tablet regimen combining bictegravir and lenacapavir for virologically suppressed adults with HIV. News also covers developments related to lenacapavir as a long‑acting option for HIV prevention and treatment, as well as agreements affecting key products like Biktarvy, including patent settlements disclosed by the company.
Oncology and cell therapy news is another major theme. Through Kite, a Gilead company, GILD‑related releases feature data on Yescarta for relapsed or refractory large B‑cell lymphoma, next‑generation bicistronic CAR T‑cell candidates KITE‑753 and KITE‑363 for B‑cell lymphomas, and anitocabtagene autoleucel (anito‑cel) for relapsed or refractory multiple myeloma. Updates often include efficacy and safety results from pivotal and early‑stage trials, as well as details on collaborations such as the partnership with Arcellx on anito‑cel and the research collaboration with OncoNano Medicine on ON‑BOARD encapsulation technology.
Gilead news also reflects broader corporate and policy activity, including agreements with the U.S. government related to drug pricing and access, philanthropic grants from the Gilead Foundation for metastatic breast cancer support, leadership appointments, investor conference presentations and quarterly financial announcements. Bookmark this page to monitor how these scientific, commercial, governance and access‑related developments shape the ongoing story of GILD.
Gilead Sciences reported Q1 2021 revenue of $6.4 billion, a 16% increase from 2020, driven by sales of Veklury and new oncology products. Diluted EPS rose 12% to $1.37, with non-GAAP EPS at $2.08, up 24%. Despite strong growth, sales from non-Veklury products fell 11% to $4.9 billion, mostly due to loss of exclusivity of key HIV drugs. Gilead expects 2021 revenue guidance of $23.7 billion to $25.1 billion and modified GAAP EPS guidance to $4.75 to $5.45.
Gilead Sciences (Nasdaq: GILD) is responding to the COVID-19 surge in India by offering technical support to its licensing partners. The company will enhance local manufacturing of remdesivir, approved for use in severe COVID-19 cases, and is donating at least 450,000 vials to Indian patients. Gilead’s voluntary licensing program has already provided access to the drug for over 2.3 million individuals in more than 60 countries. The company's focused efforts aim to address the urgent healthcare needs amid the crisis.
Gilead Sciences, Inc. (Nasdaq: GILD) will release its first quarter 2021 financial results on April 29, after market close. A conference call is scheduled for 4:30 p.m. Eastern Time the same day to discuss these results and provide a business update. Investors can access the live webcast through Gilead's Investors page or by dialing in with provided numbers. The webcast will be available for one year on Gilead's website. The company focuses on innovative medicines for life-threatening diseases, operating in over 35 countries worldwide.
Gilead Sciences (Nasdaq: GILD) received FDA accelerated approval for Trodelvy (sacituzumab govitecan-hziy) to treat adult patients with advanced urothelial cancer previously treated with platinum chemotherapy and PD-1/PD-L1 inhibitors. The approval is based on the Phase 2 TROPHY study, where 27.7% of 112 evaluable patients responded to the treatment, with a median response duration of 7.2 months. The approval highlights the need for new therapies in a market where the 5-year survival rate for metastatic UC is only 5.5%. However, the treatment comes with significant safety warnings related to neutropenia and diarrhea.
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.