Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences (GILD) and Merck (MRK) announced positive Phase 2 data for their investigational oral once-weekly combination regimen of islatravir and lenacapavir for HIV treatment. The study showed that 94.2% of participants maintained viral suppression at Week 48 after switching from daily Biktarvy to the weekly regimen. Key findings include:

- Zero participants had a viral load ≥50 copies/mL at Week 48
- Treatment-related adverse events were experienced by 19.2% of participants in the islatravir + lenacapavir group
- No grade 3 or 4 treatment-related adverse events were reported
- The combination is advancing to Phase 3 trials

This investigational regimen has the potential to become the first weekly oral HIV treatment, offering a novel option for people living with HIV.

Gilead Sciences (Nasdaq: GILD) has announced that it will release its third quarter 2024 financial results on Wednesday, November 6, 2024, after the market closes. The company's management will host a webcast at 4:30 p.m. Eastern Time to discuss the results and provide a business update.

A live webcast will be available on the Investor Relations section of www.gilead.com and will be archived there for one year. Gilead Sciences is a biopharmaceutical company known for its breakthroughs in medicine, focusing on innovative treatments for life-threatening diseases such as HIV, viral hepatitis, COVID-19, and cancer. The company operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead Sciences (Nasdaq: GILD) will present new research findings at IDWeek 2024 from October 16-19, covering HIV, COVID-19, and viral hepatitis. Highlights include data from 31 presentations, including pivotal Phase 3 trials PURPOSE 1 & 2 for HIV prevention. Gilead will also share results of long-term studies on Biktarvy and Sunlenca for multi-drug resistant HIV. In COVID-19 research, real-world evidence supports Veklury (remdesivir) as a standard care for hospitalized patients, while investigational obeldesivir shows promise for RSV treatment. The company continues to advance its antiviral portfolio to address global health challenges.

A new report titled 'Going the Extra Mile to End the HIV Epidemic' highlights that every country worldwide must do more to end the HIV epidemic. The report, commissioned by Gilead Sciences (GILD), offers a roadmap to help countries achieve the United Nations' goal of eliminating HIV by 2030. Despite having the necessary tools and resources, no country is close to this goal.

The report examines programs in nine Western countries and emphasizes the need for national strategies focused on four key areas: broader use of prevention, large-scale screening for diagnosis, expansion of community-based care, and use of tools to measure quality of life. It also addresses social factors like stigma, discrimination, and health equity that hinder progress.

The authors stress that while scientific innovation and healthcare access have improved, millions still live with HIV globally. They call for urgent action in the next five years to make significant progress in prevention, testing, and treatment of HIV.

Gilead Sciences presented additional data from its Phase 3 PURPOSE 2 trial at the 5th HIV Research for Prevention Conference. The trial evaluated the efficacy and safety of twice-yearly lenacapavir for HIV prevention among cisgender men and gender-diverse people. Key findings include:

1. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence.
2. Only 2 incident cases among 2,179 participants receiving lenacapavir (0.10/100 person-years).
3. Lenacapavir was 89% more effective than once-daily Truvada.
4. The trial included a diverse population across 7 countries, with 67% non-White participants.

Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024. The company has also signed voluntary licensing agreements with six pharmaceutical companies to manufacture low-cost versions for 120 low- and lower-middle income countries.

Hetero, a leading Indian pharmaceutical company, has signed a non-exclusive, royalty-free voluntary licensing agreement with Gilead Sciences to manufacture and distribute lenacapavir in 120 primarily low- and lower-middle income countries. This partnership aims to expand access to this innovative HIV treatment and prevention drug in high-incidence, resource- areas.

Lenacapavir is a breakthrough HIV-1 capsid inhibitor that works with other antiretrovirals to treat multi-drug-resistant HIV-1 infections. Recent clinical trials showed it reduced HIV infections by 96% compared to background incidence. The drug can be administered every six months via subcutaneous injection, making it a promising long-acting option for both treatment and prevention.

Hetero, with its extensive experience in HIV/AIDS care, plans to leverage its research, manufacturing, and distribution capabilities to rapidly expand access to affordable lenacapavir in underserved regions.

Gilead Sciences (GILD) has signed royalty-free voluntary licensing agreements with six generic manufacturers to increase access to lenacapavir for HIV prevention in 120 high-incidence, resource- countries. The agreements cover lenacapavir for HIV prevention and treatment in heavily treatment-experienced adults with multi-drug resistant HIV.

Gilead plans to price the product at no profit and supply lenacapavir until generic manufacturers fully support demand. The company will prioritize registration in 18 countries representing about 70% of the HIV burden in the licensed territories. Gilead aims to begin regulatory filings for lenacapavir for PrEP by the end of 2024, based on positive results from two pivotal Phase 3 trials.

This strategy aligns with Gilead's vision of ending the HIV epidemic globally and reflects input from over 100 global health stakeholders.

Gilead Sciences' Vice President of Research Oncology, Jackson Egen, is leading efforts to develop next-generation cancer therapies. Drawing from his experience with Nobel laureate James Allison, Egen emphasizes the importance of understanding immune system fundamentals to create more effective cancer treatments. Gilead's immuno-oncology strategy focuses on:

• Harnessing the immune system to fight cancer
• Developing methods to trigger cancer cell self-destruction
• Disrupting tumor-promoting cellular environments

The company aims to create effective therapies with reduced side effects. Egen highlights Gilead's collaborative approach and commitment to bench-to-bedside research as key factors in driving innovation in oncology.

Gilead Sciences, a leading biopharmaceutical company, reaffirms its commitment to ending the HIV epidemic through continued innovation in treatment and prevention. The company, headquartered in Foster City, California, operates in over 35 countries worldwide, focusing on developing innovative medicines for unmet medical needs.

Gilead's approach involves creating solutions that address the diverse needs of all people affected by HIV. The company's work builds on its legacy in HIV research and treatment, aiming to transform and simplify care for people with life-threatening illnesses globally.

While specific details about new discoveries or products are not provided, Gilead emphasizes its ongoing efforts to contribute to scientific advancements in the field of HIV research and care.