Gilead Sciences Inc Stock Price, News & Analysis

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.

Gilead Sciences, Inc. (Nasdaq: GILD) has declared a cash dividend of $0.68 per share of common stock for Q4 2020. This dividend is payable on December 30, 2020, to stockholders on record by December 15, 2020. The company focuses on the discovery and development of innovative medicines for serious illnesses. Gilead operates in over 35 countries, aiming to enhance patient care worldwide.

Gilead Sciences (Nasdaq: GILD) reported third-quarter 2020 revenues of $6.6 billion, a 17% increase from $5.6 billion in Q3 2019. Product sales rose 18%, attributed mainly to strong demand for HIV products and the COVID-19 treatment, Veklury, which generated $873 million. GAAP net income was $360 million ($0.29 EPS), a turnaround from a net loss in Q3 2019. Non-GAAP net income reached $2.7 billion ($2.11 EPS), reflecting a 27% year-over-year increase. However, HCV product sales significantly declined by 31%. Gilead's updated 2020 revenue guidance reflects the ongoing impact of the COVID-19 pandemic.

Gilead Sciences announced the completion of its acquisition of Immunomedics for approximately $21 billion. This strategic move aims to enhance Gilead's oncology portfolio, particularly through the integration of Immunomedics' lead asset, Trodelvy, which is the first FDA-approved ADC for treating metastatic triple-negative breast cancer. Gilead's CEO, Daniel O'Day, emphasized the focus on expanding Trodelvy's market reach and exploring its potential across various cancer types. Following the merger, Immunomedics will operate as a wholly owned subsidiary of Gilead.

Gilead Sciences (GILD) has announced FDA approval for its antiviral drug Veklury (remdesivir) as the first approved COVID-19 treatment in the U.S. This approval follows emergency use authorization and is based on significant clinical trial data. Veklury demonstrated a reduced recovery time in hospitalized patients, improving recovery by an average of five days compared to placebo. The drug is now available nationwide, supported by expanded manufacturing capacity. Veklury is indicated for adults and pediatric patients aged 12 and older requiring hospitalization.

Gilead Sciences (Nasdaq: GILD) announced the appointment of Anthony Welters to its Board of Directors. Welters, a former Senior Adviser at UnitedHealth Group, brings significant experience in health insurance and managed care. His leadership roles include being Executive Vice President at UHG and founding AmeriChoice. Currently, he is involved with several organizations, providing insights into healthcare delivery. Gilead's CEO, Daniel O’Day, expressed confidence that Welters' expertise will enhance the board's ability to deliver transformational medicines to patients in need.