Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences (GILD) has announced it will release its first quarter 2025 financial results on Thursday, April 24, 2025, after market close. The company's management will host a webcast at 4:30 p.m. Eastern Time to discuss the quarterly results and provide a business update.

The live webcast will be accessible through the Investors section of Gilead's website and will remain archived there for one year. The biopharmaceutical company, headquartered in Foster City, California, operates in more than 35 countries and focuses on developing innovative medicines for life-threatening diseases including HIV, viral hepatitis, COVID-19, and cancer.

The Center for Disease Analysis Foundation (CDAF) has announced $782,000 in funding for its third round of Relink program grantees, benefiting six healthcare institutions across different states. The program, funded by an $8 million grant from Gilead Sciences (GILD), aims to reconnect diagnosed but untreated Hepatitis C (HCV) and Hepatitis B (HBV) patients to care.

This initiative represents the largest global effort to support the World Health Organization's 2030 Viral Hepatitis Elimination goals in the United States. Despite progress in the last decade, patient retention remains challenging due to fragmented management systems. The program focuses on implementing culturally appropriate and innovative programs to improve relinkage to care.

The fourth and final round of proposals will open in September 2025, with priority given to state health agencies and their partners.

Gilead Sciences (GILD) presented breakthrough HIV treatment data at CROI 2025, highlighting three major developments:

1. Biktarvy demonstrated high efficacy in HIV/HBV co-infection treatment, maintaining 95.4% HIV-1 and 86.6% HBV virologic suppression rates after 96 weeks.

2. The FDA granted Breakthrough Therapy Designation to a novel twice-yearly treatment combination of lenacapavir with broadly neutralizing antibodies (teropavimab and zinlirvimab). Phase 2 results showed 96% of participants maintained viral suppression at Week 26.

3. Results from the first HIV cure trial in South Africa showed that 30% of participants remained off antiretroviral therapy through Week 48, though the trial regimen alone was deemed insufficient as a cure.

Gilead Sciences (GILD) has presented groundbreaking Phase 1 data for its once-yearly lenacapavir formulation for HIV prevention at CROI 2025. The study evaluated two different 5000mg intramuscular formulations in 40 healthy adults, demonstrating sustained plasma concentrations above effective levels for at least 56 weeks.

The trial showed promising results with median trough concentrations at Week 52 (57.0 ng/mL and 65.6 ng/mL) exceeding those observed in previous twice-yearly trials. Both formulations were well-tolerated, with injection site pain being the most common side effect, mostly mild and resolving within a week.

Additional data from the PURPOSE 1 trial revealed that approximately two-thirds of participants preferred twice-yearly lenacapavir injections over daily oral pills at Week 52. The company plans to launch a Phase 3 study for once-yearly lenacapavir in the second half of 2025.

Gilead Sciences (GILD) announced that the European Medicines Agency (EMA) has validated for parallel accelerated review its Marketing Authorization Application (MAA) and EU-Medicines for all (EU-M4all) application for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for HIV prevention.

The applications are supported by data from Phase 3 trials: PURPOSE 1 showed 100% risk reduction in cisgender women, while PURPOSE 2 demonstrated 99.9% effectiveness with a 96% risk reduction among cisgender men and gender-diverse people. Both trials proved superiority compared to daily oral Truvada.

The EU MAA will cover all 27 EU Member States plus Norway, Iceland, and Liechtenstein. The EU-M4all application aims to facilitate expedited reviews in low and lower-middle-income countries. This follows the FDA's acceptance of Gilead's New Drug Applications for lenacapavir under priority review.

Gilead Sciences (GILD) has received conditional marketing authorization from the European Commission for seladelpar, a treatment for primary biliary cholangitis (PBC). The drug will be used in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA alone, or as monotherapy for those unable to tolerate UDCA.

The approval is based on the Phase 3 RESPONSE study results, where 62% of participants taking seladelpar achieved composite biochemical response at Month 12, compared to 20% for placebo. Additionally, 25% of trial participants achieved normalization of ALP values, while none in the placebo group did. The drug also showed significant improvement in pruritus symptoms.

PBC affects approximately 163,000 people in Europe, primarily women. Seladelpar has already received accelerated approval in the U.S. in August 2024 and UK approval in January 2025. Continued authorization will be contingent on verification of clinical benefit in confirmatory trials.

Gilead Sciences (GILD) has announced its executive participation in two upcoming investor conferences in March. The company will present at the TD Cowen Annual Health Care Conference on March 4 at 11:10 AM ET and the Leerink Partners Global Healthcare Conference on March 11 at 10:40 AM ET.

Live webcasts will be available on Gilead's investor page (investors.gilead.com), with replays accessible for at least 30 days post-presentation. Gilead Sciences is a biopharmaceutical company with over three decades of breakthrough medical achievements, focusing on innovative medicines for HIV, viral hepatitis, COVID-19, and cancer treatments. The company maintains operations in more than 35 countries, with its headquarters in Foster City, California.

Gilead Sciences announced that the FDA has accepted its New Drug Application for lenacapavir, a twice-yearly injectable HIV prevention treatment, under priority review with a PDUFA date of June 19, 2025. The application follows Breakthrough Therapy Designation granted in October 2024.

The NDAs are supported by Phase 3 trials PURPOSE 1 and PURPOSE 2. PURPOSE 1 showed 100% risk reduction in cisgender women, with zero infections in the lenacapavir group. PURPOSE 2 demonstrated 99.9% effectiveness with a 96% risk reduction among cisgender men and gender-diverse people, with only two HIV infections reported.

Gilead has also submitted applications to the European Medicines Agency for review under accelerated assessment, including an EU-M4all application to facilitate availability in low and lower-middle-income countries.

Gilead Sciences (GILD) has announced a 2.6% increase in its quarterly cash dividend, which will take effect in the first quarter of 2025. The new dividend will be $0.79 per share of common stock, payable on March 28, 2025, to stockholders of record as of March 14, 2025.

The dividend increase demonstrates the company's commitment to returning value to shareholders, though future dividends will remain subject to Board approval. Gilead Sciences continues its focus on developing innovative medicines for HIV, viral hepatitis, COVID-19, cancer, and inflammation, with operations spanning more than 35 countries worldwide.