Gilead Sciences Inc #NASDAQ:GILD Price, Chart, News & Insight

Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis

Gilead Sciences will present new research at the 2025 European Association for the Study of the Liver (EASL) Congress, highlighting advancements in treating liver diseases. Key data include findings on Livdelzi (seladelpar) for primary biliary cholangitis (PBC), showing effectiveness in reducing pruritus and improving biochemical response across various patient groups. Additional presentations will feature results from studies on bulevirtide for hepatitis delta virus (HDV), including long-term virologic response after treatment cessation, and a novel hepatitis B virus (HBV) therapeutic vaccine showing early promise toward functional cure goals. Real-world data on hepatitis C virus (HCV) treatments will also be presented, supporting the global applicability of treatment guidelines. Gilead remains committed to addressing unmet needs in liver disease through scientific innovation and partnerships.

Gilead Sciences Reports Solid Q1 2025 Results Amid Strong HIV Growth, Lower Veklury Sales

Foster City, CA — Gilead Sciences (Nasdaq: GILD) reported Q1 2025 revenue of $6.7 billion, flat YoY, with product sales excluding Veklury rising 4% to $6.3 billion. The company's HIV portfolio led the performance, driven by Biktarvy sales up 7% to $3.1 billion and Descovy up 38% to $586 million.

GAAP EPS rebounded to $1.04 from a loss of $(3.34) in Q1 2024, due to non-repeating R&D impairment and acquisition charges. Non-GAAP EPS rose to $1.81, up from $(1.32) YoY. Operating income reached $2.2 billion, with a 76.7% gross margin (GAAP) and 85.5% on a non-GAAP basis.

Veklury (COVID-19 treatment) sales dropped 45% to $302 million, while Oncology sales declined 4%, including Trodelvy down 5% due to pricing and inventory dynamics. However, Liver Disease sales rose 3%, supported by growth in HBV and HDV treatment demand.

Gilead reaffirmed its 2025 revenue outlook at $28.2–$28.6 billion, and non-GAAP EPS at $7.70–$8.10, but lowered GAAP EPS guidance to $5.65–$6.05 due to expected equity investment losses and higher taxes. The company highlighted upcoming milestones, including a June PDUFA date for lenacapavir for HIV PrEP.

CEO Daniel O’Day emphasized a "strong start" to 2025 with robust HIV growth and positive pipeline progress, particularly in oncology and inflammation.

Gilead Reports Significant Progression-Free Survival Benefit from Trodelvy Plus Keytruda in Advanced Breast Cancer Study

Gilead Sciences announced positive results from its Phase 3 ASCENT-04/KEYNOTE-D19 trial, where Trodelvy (sacituzumab govitecan-hziy) combined with Keytruda (pembrolizumab) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with previously untreated, PD-L1+ metastatic triple-negative breast cancer (mTNBC). This is the first pivotal trial to show the superiority of a TROP-2 antibody-drug conjugate plus immunotherapy over standard Keytruda-chemotherapy combinations.

The study met its primary endpoint and showed early trends toward improved overall survival. No new safety signals were observed. These findings suggest a potentially practice-changing treatment option for patients with this aggressive cancer type.

Detailed data will be presented at an upcoming medical conference. The combination is investigational for this use, and Gilead plans further discussions with regulators. Gilead continues to study Trodelvy across various cancers and stages through multiple ongoing Phase 3 trials.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2025 financial results and guidance will be released on Thursday, April 24, 2025 after the market closes. At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s first quarter 2025 financial results and provide a business update.

Wall Street weighs in on Gilead as shares fall on possible U.S. HIV cuts

Investing.com -- Gilead Sciences shares dropped more than 3% Wednesday following a Wall Street Journal report that the Health and Human Services Department is considering major cuts to federal funding for domestic HIV prevention programs.

Gilead Sciences Announces Change in Chief Accounting Officer Role
March 12, 2025 – Gilead Sciences, Inc. (Nasdaq: GILD) announced the departure of Sandra Patterson, Senior Vice President, Corporate Controller, and Chief Accounting Officer.

The Board of Directors has appointed Diane E. Wilfong as interim Corporate Controller and Chief Accounting Officer, effective immediately, while the company conducts a search for a permanent successor.

About Diane Wilfong:

Previously served as Gilead’s Chief Accounting Officer (2016-2023)
Former Vice President, Controller, and Principal Accounting Officer at DXC Technology, Caesars Entertainment, and Eastman Kodak
Certified Public Accountant (inactive)
Holds a B.S. in Business Administration from UNC-Chapel Hill

Gilead Sciences presented new HIV treatment and cure research at CROI 2025, showcasing advancements in long-acting therapies and investigational cure strategies. The company highlighted the long-term efficacy of Biktarvy in people with HIV and HBV coinfection, showing high viral suppression rates in a Phase 3 study.

Gilead also announced that its investigational long-acting treatment regimen, combining lenacapavir with broadly neutralizing antibodies (bNAbs), met its primary endpoint in a Phase 2 study and received Breakthrough Therapy Designation from the FDA. This twice-yearly injectable therapy demonstrated strong efficacy, with 96% of participants maintaining viral suppression at 26 weeks.

Additionally, results from the first HIV cure clinical trial conducted in South Africa were presented. The study tested a combination of investigational compounds, including vesatolimod and bNAbs, in individuals who had been virologically suppressed. While the approach did not achieve a complete cure, the findings provide insights for future cure strategies.

Gilead remains committed to developing innovative treatments for HIV, with ongoing research into long-acting therapies and potential cure approaches.

Gilead Sciences presented the first clinical data on its investigational once-yearly injectable lenacapavir for HIV prevention at the CROI 2025 conference, with findings also published in *The Lancet*. The Phase 1 study demonstrated that two formulations of intramuscular lenacapavir maintained plasma concentrations above levels associated with HIV prevention efficacy for over 52 weeks. Based on these results, Gilead plans to initiate a Phase 3 trial in the second half of 2025.

The study, which included 40 healthy adults, showed that both formulations of lenacapavir achieved higher median trough concentrations than the twice-yearly subcutaneous formulation used in previous trials. Safety data indicated that the drug was well tolerated, with the most common side effect being mild, temporary injection site pain.

Additional findings presented at CROI included survey results from the PURPOSE 1 trial, showing that most participants preferred twice-yearly injections over daily oral PrEP. Adolescents in the study reported similar pharmacokinetic and safety profiles as adults, with no new HIV infections observed among those receiving lenacapavir.

Lenacapavir, already approved in multiple countries for treating drug-resistant HIV, is being evaluated as a long-acting PrEP option. Gilead's PURPOSE program, the most comprehensive HIV prevention trial series to date, is assessing the drug’s potential in diverse populations. The company remains committed to advancing innovative HIV treatments and prevention strategies.

A new report from PatientView highlights the continued importance of environmental, social, and governance (ESG) policies in shaping patient groups' perceptions of major pharmaceutical companies. Despite declining corporate interest and increasing political opposition to ESG in the U.S., the survey of 701 patient groups found that 94% consider a company's social impact important, followed by 88% prioritizing corporate governance and 67% emphasizing environmental practices.

When ranking 15 major drugmakers on ESG performance, Roche was rated highest overall, followed by Gilead Sciences and Johnson & Johnson Innovative Medicine. Among companies that patient groups have directly partnered with, Gilead took the top spot, followed by Roche and AstraZeneca.

The report also suggests that patient groups want clearer communication and more concrete actions from pharma companies regarding ESG initiatives. While the study underscores ESG's relevance to patient organizations, broader business support for ESG is wavering. A GlobalData survey found that only 8% of people believe ESG will significantly impact their business in the next year, down from 20% in 2022.

In the U.S., ESG has become a contentious issue, with multiple states enacting laws against such policies. PatientView noted that fewer U.S. patient groups participated in this survey compared to past pharma-related studies, likely reflecting the growing controversy surrounding ESG commitments.

Source: Fierce Pharma

Gilead Sciences, Inc. (Nasdaq: GILD) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) and EU-Medicines for All (EU-M4all) application for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP). The applications will be assessed in parallel under an accelerated review timeline, recognizing lenacapavir’s potential public health impact.

The EU MAA will undergo centralized review across 27 EU Member States, along with Norway, Iceland, and Liechtenstein, while the EU-M4all application aims to facilitate expedited approvals in low- and lower-middle-income countries. This development follows the U.S. FDA’s acceptance of New Drug Applications (NDAs) for lenacapavir under priority review.

The EMA’s validation is supported by results from Phase 3 PURPOSE 1 and PURPOSE 2 trials, which demonstrated high efficacy in reducing HIV infection rates. In PURPOSE 1, the lenacapavir group showed zero infections, while PURPOSE 2 recorded a 96% risk reduction in HIV infections compared to background HIV incidence.

If approved, lenacapavir could transform global HIV prevention efforts as a long-acting, twice-yearly PrEP option, offering an alternative to daily oral Truvada (F/TDF). Gilead is actively working on an access strategy to expedite global availability.

Lenacapavir for HIV prevention remains investigational and has not yet received approval worldwide.

Source: Gilead Sciences, "European Medicines Agency Validates Gilead’s Marketing Authorization Application for Twice-Yearly Lenacapavir for HIV Prevention," February 24, 2025.

Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis

Gilead - U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review

Marginal Zone Lymphoma Market to Reach New Heights in Growth by 2034, DelveInsight Predicts | Gilead Sciences, AstraZeneca, Nordic Nanovector, Christian Buske, AbbVie, Pharmacyclics LLC, Hutchison Med

The Key Marginal Zone Lymphoma Companies in the market include - Bristol-Myers Squibb, TG Therapeutics, Gilead Sciences, AstraZeneca, Nordic Nanovector, Christian Buske, AbbVie, Pharmacyclics LLC, Hutchison Medipharma, Beigene, Incyte Corporation, Enterome, and others. DelveInsight’s “Marginal Zone Lymphoma Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the...

Cognizant Technology Solutions and Gilead Sciences have announced an expansion of their partnership. Cognizant will leverage its Neuro AI generative AI platform to assist Gilead in accelerating value creation, enhancing IT and business processes, and improving operational efficiencies. This initiative aims to provide significant cost savings, which can be reinvested into Gilead's core life sciences business. The collaboration focuses on multiple use cases across customer service, employee interactions, and business value management. Gilead expects to enhance its efficiency by leveraging Cognizant's expertise in AI and advanced technology applications.

Over the last decade, Cognizant has supported Gilead's global IT infrastructure, platforms, applications, and advanced analytics, leading initiatives designed to accelerate its digital transformation. This expanded agreement builds on their collaboration aimed at creating capacity to allow Gilead to continue its focus and mission of discovering and delivering critical medicines for cancer, HIV, and other diseases.

In July 2023, Cognizant and Gilead extended their partnership with a five-year service agreement estimated at $800 million. Under that agreement, Cognizant manages Gilead's global IT infrastructure, platforms, applications, and advanced analytics, leading initiatives designed to accelerate its digital transformation. The collaboration aims to enable Gilead to streamline various parts of its business with the goal of faster time to market for various medicines for life-threatening diseases, including HIV, viral hepatitis, and cancer.

As of January 30, 2025, Cognizant's stock (CTSH) is trading at $82.98, reflecting an increase of 2.21% from the previous close. Gilead Sciences' stock (GILD) is trading at $96.75, up 1.21% from the prior close.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2024 financial results and 2025 guidance will be released on Tuesday, February 11, 2025, after the market closes. At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s fourth quarter and full year 2024 financial results and provide a business update.

A live webcast will be available in the Investors section of www.gilead.com and will be archived there for one year.

Analysts Offer Insights on Healthcare Companies: Lyell Immunopharma (LYEL) and Gilead Sciences (GILD) | Markets Insider

Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Lyell Immunopharma (LYEL – Research Report) a...

Gilead Sciences, US government settle patent case over HIV prevention drugs

Gilead Sciences and the U.S. government have settled a billion-dollar patent dispute over Gilead's HIV prevention drugs Truvada and Descovy, according to a Wednesday filing in Delaware federal court. The settlement follows a victory for Gilead in a 2023 jury trial on the government's patent infringement allegations. Gilead General Counsel Deborah Telman said in a statement that the agreement "allows Gilead to continue to focus its resources on its mission to discover, develop, and deliver innovative therapeutics to people with life-threatening diseases."

Global Financial Private Client LLC Grows Stock Holdings in Gilead Sciences, Inc. (NASDAQ:GILD)

Global Financial Private Client LLC boosted its position in shares of Gilead Sciences, Inc. (NASDAQ:GILD - Free Report) by 1,222.0% in the fourth quarter, according to its most recent filing with the Securities &amp; Exchange Commission. The fund owned 6,068 shares of the biopharmaceutical company'

Gilead Sciences: Supreme Court Case and New Innovations Drive Buy Rating | Markets Insider

Michael Yee, an analyst from Jefferies, maintained the Buy rating on Gilead Sciences (GILD – Research Report). The associated price target remai...

Gilead, LEO Pharma Partner in $1.7 Billion Deal for Inflammatory Disease Therapies

Gilead gains global rights to oral STAT6 treatments.

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