Gilead Sciences Inc - GILD STOCK NEWS

Kite, a Gilead Company (Nasdaq: GILD), has received FDA approval for its retroviral vector manufacturing facility in Oceanside, California. This facility is crucial for producing viral vectors, which are essential in Kite's CAR T-cell therapies aimed at treating blood cancers. Kite stands out as the only cell therapy company with both commercial and clinical trial viral vector manufacturing capabilities. The in-house production will enhance reliability and scalability, meeting increasing patient demand for these therapies.

Gilead Sciences has launched a multi-year, public-private initiative in collaboration with the Partnership for Health Advancement in Vietnam (HAIVN) to enhance hepatitis care and management in Vietnam and the Philippines. This program aims to integrate hepatitis B and C diagnosis and treatment into primary healthcare, addressing barriers to access. With significant hepatitis prevalence in both countries, the initiative aligns with WHO targets for viral hepatitis elimination by 2030, hoping to strengthen healthcare systems and broaden patient access to care.

Gilead Sciences, Inc. (GILD) has successfully completed the acquisition of MiroBio for $405 million in cash. MiroBio, a U.K.-based biotechnology firm, specializes in immune inhibitory receptor agonists. This acquisition grants Gilead access to MiroBio's proprietary discovery platform and its lead investigational antibody, MB272, which is currently in Phase 1 clinical trials. Gilead aims to enhance its portfolio in inflammatory diseases, addressing unmet medical needs.

Kite, a Gilead Company, announced a positive opinion from the European Medicines Agency for Yescarta, a CAR T-cell therapy, for adults with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months post-first-line chemoimmunotherapy. The ZUMA-7 study showed a four-fold improvement in event-free survival at two years (41% for Yescarta vs. 16% for standard care). The final decision from the European Commission is expected soon, potentially transforming treatment for these aggressive lymphomas.

Gilead Sciences announced a positive opinion from the European Medicines Agency (EMA) regarding its COVID-19 treatment, Veklury (remdesivir), for pediatric patients under 12 years. If approved by the European Commission, Veklury would be the only authorized antiviral treatment for this demographic, specifically for children at risk of severe COVID-19 or with pneumonia requiring oxygen. The decision is based on positive results from the ongoing CARAVAN Phase 2/3 study, which showed clinical improvement in 75-85% of pediatric participants.

Gilead Sciences announced that the World Health Organization (WHO) has updated its guidelines to include a conditional recommendation for Veklury (remdesivir) in treating both severe and non-severe COVID-19 patients at high risk of hospitalization. The decision stems from the SOLIDARITY study, demonstrating a 17% reduction in the risk of death or progression to ventilation in patients requiring supplemental oxygen. Over 11 million patients globally have received Veklury.

Gilead Sciences announces a $20 million commitment through its Creating Possible Fund to support 13 U.S. organizations focused on education and health equity. This initiative aims to build a pipeline of Black health leaders and enhance educational opportunities for underserved students. Recognizing the interconnectedness of education and health disparities, the fund will finance innovative projects that improve learning environments and social support systems. Gilead's ongoing dedication to health equity is underscored by its collaboration with local communities and organizations.

Gilead Sciences announced positive results from the Phase 3 TROPiCS-02 study, showing Trodelvy improved overall survival by 3.2 months in patients with HR+/HER2- metastatic breast cancer who had received prior therapies. Median overall survival was 14.4 months for Trodelvy compared to 11.2 months for chemotherapy. The results, highlighting Trodelvy's potential in both pre-treated HR+/HER2- and triple-negative breast cancers, will be presented at the ESMO Congress 2022. Gilead has submitted a supplemental Biologics License Application to the FDA for Trodelvy's use in HR+/HER2- metastatic breast cancer.

Kite, a Gilead Company (GILD), announced the European Commission has approved its CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This approval is significant as it is the first CAR T-cell therapy for this patient population. The ZUMA-3 trial showed a 71% complete remission rate and a median overall survival of over two years. Kite emphasizes Tecartus addresses a critical unmet medical need for patients with few treatment options.