Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (GILD) announced its program for the 25th International AIDS Conference (AIDS 2024), highlighting advancements in HIV prevention, treatment, and cure research. Key highlights include:

1. Full data from the PURPOSE 1 trial on lenacapavir, a twice-yearly HIV prevention medicine.

2. Week 48 outcomes from ARTISTRY-1 study on a single-tablet regimen of bictegravir and lenacapavir.

3. Two-year outcomes from BICSTaR study on Biktarvy®.

4. New data on GS-1720 and GS-4182 for potential once-weekly oral HIV treatments.

5. Resistance analyses for lenacapavir + teropavimab + zinlirvimab combination.

Gilead will also host symposia on addressing barriers to HIV care and prevention, and showcase initiatives aimed at improving HIV awareness and care.

Gilead announced a significant enhancement to its employee benefits by introducing AccessHope, a cancer care support program, to its U.S. employees and their families. This initiative provides access to a network of oncology professionals offering treatment information and emotional support. Jim Candler, a Senior Director at Gilead, shared his positive experience with AccessHope after being diagnosed with prostate cancer. He emphasized the program's role in helping him and his wife navigate treatment options. Additionally, Gilead's efforts in cancer care caught the attention of President Biden's Cancer Moonshot initiative, leading to an invitation to the White House to discuss employer-led cancer screening practices. This initiative highlights Gilead's commitment to employee wellbeing and innovative cancer treatment options.

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.