Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences has declared a 2.8% increase in its quarterly cash dividend, raising it to $0.73 per share. The new dividend will take effect in the first quarter of 2022.

Shareholders of record by March 15, 2022 will receive the dividend on March 30, 2022. Future dividends are subject to Board approval, reflecting Gilead’s ongoing commitment to rewarding its investors.

Gilead Sciences reported a 2% decrease in fourth quarter 2021 revenue to $7.2 billion, impacted by lower Veklury sales, despite a 19% year-over-year increase in Biktarvy sales. The diluted EPS fell to $0.30 due to a $1.25 billion legal settlement charge and a $625 million Arcus opt-in charge. Full-year 2021 revenue rose to $27.3 billion, with EPS increasing to $4.93, helped by Veklury's 98% growth. R&D expenses rose to $5.4 billion, reflecting ongoing clinical commitments. 2022 guidance anticipates product sales of $23.8-$24.3 billion and EPS between $4.70 and $5.20.

FDA Approves Update for Yescarta: Gilead's Kite has received FDA approval for an update to the prescribing information of Yescarta (axicabtagene ciloleucel). This update allows for the use of prophylactic corticosteroids across all approved indications, marking Yescarta as the first CAR T-cell therapy with guidelines for managing treatment-related side effects. The update is based on a safety management cohort from the ZUMA-1 study, showing a significant reduction in severe cytokine release syndrome (CRS) events compared to prior cohorts.

Gilead Sciences (Nasdaq: GILD) has announced a partial clinical hold on studies evaluating the combination of magrolimab and azacitidine due to suspected unexpected serious adverse reactions (SUSARs). This hold will pause new patient enrollment in the affected studies while current participants can continue receiving treatment. Other magrolimab studies remain unaffected. Gilead is collaborating with regulatory authorities to determine next steps and emphasizes patient safety as a priority.

Gilead Sciences announced the FDA's expedited approval of Veklury (remdesivir) for non-hospitalized adults and adolescents at high risk of severe COVID-19. The approval allows outpatient administration over three days and expands the pediatric EUA to include children under 12. Veklury showed an 87% reduction in hospitalization risk in clinical trials. This development comes amid rising COVID-19 cases and variants' impact on treatment options.

Gilead is committed to ensuring availability in outpatient settings while maintaining supply for hospitalized patients.

Gilead Sciences, Inc. (NASDAQ: GILD) announced that it will release its fourth quarter and full year 2021 financial results on February 1, after market close. Management will discuss these results in a live webcast at 4:30 PM ET on the same day. Investors can access the webcast through Gilead's investor relations page and it will be archived for one year. Gilead has been a leader in biopharmaceuticals for over three decades, focusing on innovative treatments for serious diseases such as HIV, hepatitis, and cancer.

Gilead Sciences (NASDAQ: GILD) announced collaborations with Merck to evaluate Trodelvy in combination with KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer (NSCLC). Merck will sponsor a global Phase 3 trial, while Gilead will conduct a Phase 2 study. NSCLC, as the leading lung cancer type, presents a significant unmet medical need due to a low five-year survival rate of 25%. Trodelvy, currently approved for certain cancers, is under investigation for this new indication, and the safety and efficacy for NSCLC treatment remain unestablished.

Gilead Sciences (GILD) announced positive results from a Phase 3 study of Veklury (remdesivir) for treating COVID-19 in non-hospitalized patients at high risk of disease progression. The study reported an 87% reduction in hospitalization or death risk and an 81% reduction in medical visits compared to placebo. Subgroup analyses showed consistent efficacy for patients with comorbidities. Although investigational, these findings are submitted to the FDA for approval, emphasizing Veklury's crucial role in outpatient care.

Gilead Sciences announced a clinical hold imposed by the FDA on injectable lenacapavir for HIV treatment and PrEP due to compatibility issues with borosilicate vials. This hold affects ongoing studies, preventing enrollment and dosing of injectable lenacapavir. However, oral lenacapavir formulations remain unaffected. Gilead is committed to resolving the vial quality issue promptly, noting that lenacapavir is still under investigation and not yet approved. The company emphasized its dedication to addressing this challenge and advancing research on HIV treatments.