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Gilead Sciences, Inc. (GILD) is a leading biopharmaceutical company focused on developing innovative therapies for life-threatening diseases. This page provides investors and healthcare professionals with timely updates on the company's latest developments, regulatory milestones, and strategic initiatives.
Access comprehensive coverage of Gilead's press releases and news, including updates on antiviral therapies, oncology research, and clinical trial results. Our curated collection features earnings announcements, partnership details, and progress reports on treatments for HIV, hepatitis, and emerging cancer therapies.
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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.
Gilead Sciences (Nasdaq: GILD) announced groundbreaking results from its PURPOSE 2 trial, evaluating twice-yearly injectable lenacapavir for HIV prevention. The drug reduced HIV infections by 96% compared to background HIV incidence, with only 2 incident cases among 2,180 participants. Lenacapavir also demonstrated superiority to daily Truvada, showing 89% greater effectiveness. The trial included diverse participants from seven countries.
Key findings:
- 99.9% of participants did not acquire HIV in the lenacapavir group
- Lenacapavir was 96% more effective than background HIV incidence
- 89% more effective than once-daily Truvada
- Generally well-tolerated with no significant safety concerns
Gilead plans to begin global regulatory filings by the end of 2024, potentially launching the first twice-yearly HIV prevention option in 2025.
Gilead Sciences has been recognized as a Leading Inclusion Index Company by Seramount, highlighting its commitment to fostering connections, creating opportunities for underrepresented groups, and cultivating a sense of belonging. This prestigious acknowledgment places Gilead among 42 organizations receiving this distinction in 2024.
Gilead Sciences is a research-based biopharmaceutical company that focuses on discovering, developing, and commercializing innovative medicines for unmet medical needs. The company aims to transform and simplify care for people with life-threatening illnesses globally. With operations in over 35 countries and headquarters in Foster City, California, Gilead continues to make strides in both medical innovation and workplace inclusion.
Gilead Sciences (GILD) and Genesis Therapeutics have announced a strategic collaboration to discover and develop novel small molecule therapies. The partnership will leverage Genesis' GEMS AI platform to generate and optimize molecules for targets selected by Gilead. Key points include:
- Gilead receives exclusive rights for clinical development and commercialization of collaboration compounds
- Genesis will receive a $35 million upfront payment across three targets
- Additional preclinical, development, regulatory, and commercial milestone payments possible
- Genesis eligible for tiered royalties on net sales
- The deal is expected to reduce Gilead's 2024 EPS by approximately $0.02
This collaboration aims to accelerate drug discovery for challenging targets using generative AI technologies.
Maria Morais, a registered nurse, was diagnosed with primary biliary cholangitis (PBC) in 2018, a rare autoimmune liver disease affecting approximately 130,000 people in the United States. Her journey from diagnosis to liver transplant highlights the challenges faced by PBC patients. Despite initial treatment, Maria's condition progressed rapidly, causing severe symptoms like uncontrollable itching and fluid accumulation in her abdomen. By 2020, she required a liver transplant, receiving 60% of a liver from a friend. Post-transplant, Maria became a patient advocate and peer counselor for others with rare liver diseases. She emphasizes the need for more research and treatment options to address PBC symptoms like itching, fatigue, brain fog, and fluid build-up. Maria's story underscores the importance of awareness and continued efforts to improve the lives of those living with PBC.
Gilead Sciences (Nasdaq: GILD) will present new data on Trodelvy® during the IASLC 2024 World Conference on Lung Cancer from Sept. 7-10, 2024, in San Diego. Key presentations include:
- Initial results from two cohorts of the EVOKE-02 study on Trodelvy in untreated advanced or metastatic non-small cell lung cancer (mNSCLC).
- Subgroup analysis from the EVOKE-01 study showing overall survival improvement in second-line mNSCLC patients non-responsive to prior anti-PD-(L)1 therapy.
- Updated data from the TROPiCS-03 study in extensive stage small cell lung cancer (ES-SCLC).
These findings highlight Trodelvy's potential efficacy for mNSCLC and ES-SCLC, supporting broader investigation and ongoing Phase 3 trials. Trodelvy's safety and efficacy are still under review for these conditions. Trodelvy has a Boxed Warning for severe neutropenia and diarrhea. For more details, please refer to the safety information.
