Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences received a complete response letter (CRL) from the FDA regarding its New Drug Application for lenacapavir, a long-acting HIV-1 capsid inhibitor. The CRL cites compatibility issues between lenacapavir and the proposed container vial, resulting in a clinical hold on the injectable formulation. Gilead plans to address these concerns and submit data for an alternative vial type. The NDA for lenacapavir was submitted in June 2021, supported by Phase 2/3 trial data, but it remains under review.

Gilead Sciences has announced one-year results from the CAPELLA trial, showcasing lenacapavir's efficacy in heavily treatment-experienced individuals with multi-drug resistant HIV. Administered biannually with other antiretrovirals, 83% of participants achieved undetectable viral loads, alongside a mean CD4 count increase of 83 cells/µL. Lenacapavir, a first-in-class HIV-1 capsid inhibitor, potentially addresses significant unmet needs in treatment. The ongoing CALIBRATE trial also reported high viral suppression rates in treatment-naïve patients, with 90% achieving undetectable viral loads.

Gilead Sciences (NASDAQ: GILD) announced interim data from its Phase 2/3 study of Veklury (remdesivir) for pediatric COVID-19 patients, ages 28 days to under 18 years. Presented at CROI 2022, results indicate that 85% of children showed clinical improvement, while 83% recovered by study's end (N=53). No new safety signals were observed, with 72% experiencing adverse events, mostly mild. Gilead submitted this data to the FDA for further authorization. The study's goal is to evaluate Veklury's safety and efficacy in treating hospitalized pediatric patients with COVID-19.

Gilead Sciences (NASDAQ: GILD) presented five-year results from Phase 3 studies on Biktarvy for HIV treatment at the CROI 2022 conference. The data indicated a high efficacy rate, with over 98% of participants maintaining an undetectable viral load throughout the treatment period. Notably, zero cases of treatment failure due to resistance were reported. Long-term safety assessments revealed stable metabolic, bone, and renal markers, leading to confidence in Biktarvy's long-term use for treatment-naïve adults.

Gilead Sciences has released data demonstrating that Veklury (remdesivir) remains effective against multiple SARS-CoV-2 variants, including Delta and Omicron. The study confirms Veklury's antiviral activity against ten major variants, with consistent results across independent studies in various countries. Notably, the drug targets the conserved nsp12 protein, crucial for replication, ensuring its efficacy remains intact even as variants emerge. Veklury is widely used in the U.S., treating over half of hospitalized COVID-19 patients. This positions Gilead favorably as the demand for effective COVID-19 treatments persists.

Gilead Sciences (GILD) announced new data from its HIV and COVID-19 research programs, to be presented at CROI 2022 from February 12-16. Findings highlight the role of Veklury (remdesivir) in treating COVID-19 and showcase advancements in HIV treatment, including one-year results from the CALIBRATE and CAPELLA trials on lenacapavir. Gilead affirms its commitment to addressing unmet health needs through innovative research, especially amidst ongoing global health challenges.

Gilead Sciences (NASDAQ: GILD) announced its participation in three upcoming investor conferences. Executives will present at:

• SVB Leerink Annual Global Healthcare Conference on February 16 at 2:20 PM ET
• Raymond James Annual Institutional Investors Conference on March 8 at 1:05 PM ET
• Cowen Annual Health Care Conference on March 9 at 10:30 AM ET

Live webcasts will be available on the company’s investors page with replays accessible for at least 30 days.

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.