Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) announced interim Phase 3 trial results showcasing the 100% efficacy of its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for HIV prevention in cisgender women. The PURPOSE 1 trial concluded with zero HIV infections, demonstrating lenacapavir’s superiority over daily oral Truvada and background HIV incidence. Based on these findings, the independent Data Monitoring Committee advised halting the blinded phase and transitioning all participants to open-label lenacapavir. The trial included over 5,300 cisgender women and adolescent girls across 28 sites in South Africa and Uganda. Lenacapavir was generally well-tolerated with no new safety concerns. Gilead plans to present more detailed data at a future conference and continues additional trials under the PURPOSE program, aiming to end the HIV epidemic globally.

Gilead Sciences and Kite Pharma celebrated Pride Month by raising Pride Month flags at their campuses, showcasing their support for LGBTQ+ communities worldwide. This initiative aligns with Gilead's commitment to inclusion and diversity, which is integral to their mission of creating a healthier world. Gilead Sciences is a biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for unmet medical needs, particularly life-threatening illnesses. Headquartered in Foster City, California, Gilead operates in over 35 countries globally.

Gilead's Kite announced new data for Yescarta® (axicabtagene ciloleucel) in treating relapsed/refractory large B-cell lymphoma (R/R LBCL). Key findings indicate that using Yescarta as a second-line treatment improves manufacturing success rates by 2.60% compared to third-line treatments, achieving a 95.08% success rate in second-line therapies. Additionally, second-line treatments showed double the median percentage of naïve-like T-cells in patients, enhancing potential outcomes.

Preliminary results from the ZUMA-24 study suggest that outpatient administration of Yescarta is feasible, with safety data consistent with prior studies. These findings will be presented at the 2024 European Hematology Association Annual Congress.

On June 12, 2024, Gilead Sciences announced the contributions of Luciana Preger to their oncology advancements. Luciana, with over 20 years of experience in the pharmaceutical field, currently serves as Vice President of Global Medical Affairs, Oncology. She has been instrumental in improving patient access to cancer treatments and has overseen the development of over 10 oncology therapies with significant survival benefits. Luciana emphasizes the importance of equitable care and scientific innovation in transforming cancer treatment. Currently, Gilead's oncology portfolio has reached over 30,000 patients, and the company continues to expand its impact on difficult-to-treat tumor types.

Gilead Sciences (Nasdaq: GILD) announced that Phase 2b data from the MYR204 study on bulevirtide combined with pegylated interferon alfa-2a (PegIFN) showed promising results for chronic hepatitis delta virus (HDV) treatment. Published in NEJM, the study revealed that 46% of patients achieved undetectable HDV RNA levels at Week 24 post-treatment. Additionally, consistent results were observed at Week 48, confirming bulevirtide's potential as a finite therapy. The combination treatment exhibited a higher efficacy than monotherapy, with 32% and 46% achieving undetectable HDV RNA at Week 24 for 2 mg and 10 mg doses, respectively. Safety profiles were consistent, with common adverse events being leukopenia, neutropenia, and thrombocytopenia. The data also align with the Phase 3 MYR301 study, which highlighted bulevirtide's effectiveness and tolerability. Bulevirtide remains approved in the EEA, Great Britain, and Switzerland, but not in the U.S.

Gilead Sciences highlights the impact of breast cancer treatments on fertility, focusing on the experiences of younger women. Emma, a 28-year-old nursing student, opted for IVF and egg freezing after her diagnosis of triple-negative breast cancer, reflecting on how cancer disrupted her life plans. According to the National Breast Cancer Foundation, 9% of women diagnosed with breast cancer in the U.S. are under 45, facing potential infertility from chemotherapy. Gilead partners with organizations like the Young Survival Coalition (YSC) to support these women, stressing the importance of consulting fertility preservation experts. Amanda Nixon of YSC advises that young women consider their post-cancer treatment life and fertility options.

Gilead Sciences announced favorable two-year interim results from the ASSURE study, evaluating seladelpar as a treatment for primary biliary cholangitis (PBC). The study demonstrated rapid, sustained improvements in liver biomarkers and a reduction in pruritus (itching). In the Phase 3 RESPONSE trial, seladelpar showed a 70% composite response and 42% normalization in liver function among legacy study participants over 24 months. No serious adverse events were reported. These results were presented at the European Association for the Study of the Liver (EASL) Congress 2024, with promising implications for seladelpar's approval and potential market impact.

Kite, a Gilead company, announced long-term survival data from the ZUMA-3 study of Tecartus® (brexucabtagene autoleucel) in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The study's four-year follow-up revealed a median overall survival (OS) of 25.6 months and a 40% OS rate at 48 months. The data, presented at the 2024 ASCO Annual Meeting, showed consistent safety with previous analyses. Tecartus demonstrated survival benefits regardless of age, prior treatments, or subsequent allogeneic stem cell transplant status. Notably, patients with fewer prior therapies had better outcomes. No new adverse events were reported since the three-year analysis.

Kite, a Gilead Company (Nasdaq: GILD), presented promising data on Yescarta® for relapsed/refractory CNS lymphoma at the 2024 ASCO Annual Meeting. The pilot study, conducted with Dana-Farber Cancer Institute, revealed that Yescarta® is well-tolerated in patients with R/R central nervous system lymphoma (CNSL), showing a high objective response rate of 94.4% and a complete response rate of 66.7%. The median progression-free survival was 14.3 months, and overall survival was 26.4 months. The study showed no additional risk of adverse events, with immune effector cell-associated neurologic syndrome observed in 44% of patients. These results suggest that Yescarta could be a viable treatment option for this aggressive and rare form of lymphoma.