Gilead Sciences Inc Stock Price, News & Analysis

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.