Welcome to our dedicated page for Gilead Sciences news (Ticker: GILD), a resource for investors and traders seeking the latest updates and insights on Gilead Sciences stock.
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.
Stay informed about critical developments through verified updates on FDA approvals, research collaborations, and therapeutic advancements. All content is organized chronologically for quick reference, with clear sourcing to ensure transparency.
Bookmark this page for streamlined access to Gilead Sciences' official communications and third-party analysis. Regularly updated to reflect the company's evolving pipeline and market position, this resource supports informed decision-making for stakeholders at all levels.
Kite, a Gilead Company, announced positive five-year follow-up results from the ZUMA-5 Phase 2 study of Yescarta in patients with relapsed/refractory non-Hodgkin lymphomas. After a median follow-up of 64.6 months, the treatment showed:
- 90% overall response rate with 75% complete response
- Median progression-free survival of 62.2 months
- Median duration of response of 60.4 months
- 55% of patients alive without needing new anticancer therapy
- 69% estimated overall survival at 60 months
The study demonstrated durable response and long-term survival potential, with no new safety signals emerging in the five-year analysis. The results suggest potential curative effects for these typically difficult-to-treat blood cancers.
Kite, a Gilead company, presented compelling long-term data for Tecartus® (brexucabtagene autoleucel) at ASH 2024. Key findings include:
- 91% overall response rate and 73% complete response rate in BTKi-naïve R/R MCL patients
- 39% five-year survival rate in R/R MCL patients, making it the only CAR T therapy with such long-term data
- In ZUMA-2 cohort 3 (BTKi-naïve patients), 12-month rates showed 80% duration of response, 75% progression-free survival, and 90% overall survival
Real-world evidence in R/R B-ALL patients showed 80% complete response rate with consistent safety profile across a broader patient population than the ZUMA-3 study.
Kite, a Gilead company, presented three new analyses for Yescarta (axicabtagene ciloleucel) at the ASH Annual Meeting, demonstrating improved outcomes for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). The largest real-world evidence analysis showed a 71% overall survival rate in second-line treatment, consistent with the ZUMA-7 study results.
Key findings include a decreasing trend in cytokine release syndrome and related adverse events in third-line plus settings during 2017-2023, and stable long-term quality of life outcomes from the ALYCANTE study. The real-world analysis of 446 patients from 89 U.S. centers demonstrated a 79% overall response rate with a 64% complete response rate.
Gilead Sciences (GILD) and Tubulis have entered into an exclusive option and license agreement to develop an antibody-drug conjugate (ADC) for solid tumors. The collaboration leverages Tubulis' Tubutecan and Alco5 platforms to create a Topoisomerase I inhibitor-based ADC candidate. Gilead will pay $20 million upfront and a potential $30 million option exercise fee. Additional development and commercialization milestones could reach $415 million, plus mid-single to low double-digit royalties. Tubulis will lead early-stage R&D, while Gilead will handle development and commercialization if they exercise their option.
Gilead Sciences announced the publication of its Phase 3 PURPOSE 2 trial results in The New England Journal of Medicine, evaluating twice-yearly lenacapavir for HIV prevention. The study demonstrated 96% reduction in HIV infections compared to background incidence, with only two cases among 2,179 participants. The treatment proved superior to once-daily Truvada and was well-tolerated with no significant safety concerns.
These results align with the previous PURPOSE 1 trial, which showed 100% efficacy in cisgender women in sub-Saharan Africa. Gilead plans to begin global regulatory filings for lenacapavir for PrEP by the end of 2024, implementing an access strategy developed with input from over 100 global health advocates.
Gilead Sciences' PURPOSE 1 trial, focusing on HIV prevention in young African women and adolescent girls, represents a significant step in inclusive clinical research. The trial studies a PrEP medication administered every six months via injection and is part of the most comprehensive HIV prevention program ever conducted. The study enrolled thousands of cisgender women and girls aged 16-25 in South Africa and Uganda, including pregnant and lactating women - a first for a Phase 3 HIV prevention trial. The initiative addresses the disproportionate impact of HIV on women in sub-Saharan Africa, where approximately 3,100 women acquire HIV weekly. Preliminary results have been encouraging.
Gilead Sciences announced positive interim results from the Phase 3 ASSURE study of Livdelzi (seladelpar) in treating Primary Biliary Cholangitis (PBC). The study showed that 81% of participants achieved composite biochemical response by Month 30, and 41% achieved normalization of alkaline phosphatase levels. The drug demonstrated significant improvements in PBC progression markers with a robust safety profile, with no treatment-related serious adverse events reported. Additionally, Livdelzi reduced pruritus severity, with 27% of participants experiencing near resolution of itch symptoms. The drug received FDA accelerated approval in August 2024 for PBC treatment.
Gilead Sciences (Nasdaq: GILD) has announced the pricing of $3.5 billion in senior unsecured notes through a public offering. The notes are structured in four tranches: $750 million at 4.80% maturing in 2029, $1 billion at 5.10% maturing in 2035, $1 billion at 5.50% maturing in 2054, and $750 million at 5.60% maturing in 2064. The offering is expected to close on November 20, 2024. The company plans to use the proceeds for general corporate purposes, including potential debt repayment. Barclays Capital and BofA Securities are serving as lead joint book-running managers for the offering.
Gilead Sciences presented full results from its Phase 3 PURPOSE 2 trial studying twice-yearly lenacapavir for HIV prevention. The trial showed that lenacapavir reduced HIV infections by 96% compared to background HIV incidence, with only two cases among 2,179 participants. The drug demonstrated 89% higher effectiveness than daily Truvada.
Trial participants showed high adherence to lenacapavir injections, with 91% receiving on-time injections at week 26 and 92.8% at one year. The FDA granted Breakthrough Therapy Designation for lenacapavir for PrEP, and Gilead plans to begin regulatory filings by end of 2024.
Gilead Sciences presented new research data on its HIV treatment portfolio at HIV Glasgow 2024, including four-year outcomes from the BICSTaR study for Biktarvy®. The study demonstrated high long-term efficacy and safety, with 98% virologic suppression in treatment-naïve and 97% in treatment-experienced patients, with no treatment-emergent resistance. New data also highlighted Biktarvy's high barrier to resistance compared to other treatments. The company showcased investigational regimens with varied dosing frequencies, including once-daily, once-weekly, and twice-yearly options, focusing on person-centered drug development to address unmet needs in HIV treatment.
