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Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
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Kite, a Gilead Company (Nasdaq: GILD), presented follow-up analyses from pivotal studies ZUMA-2 and ZUMA-3 on CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and mantle cell lymphoma (MCL). Findings revealed significant overall survival advantages, with Tecartus showing improved two-year outcomes compared to standard care. Tecartus is the first CAR T-cell therapy approved for adults with these conditions. Presentations took place at the 2022 ASH Annual Meeting on December 10 and 12.
Kite, a Gilead Company (Nasdaq: GILD), announced significant three-year follow-up data from the ZUMA-5 study for Yescarta (axicabtagene ciloleucel), showing sustained response in 52% of patients with relapsed or refractory indolent non-Hodgkin lymphoma. The study reported an overall response rate (ORR) of 90% and a complete response (CR) rate of 75% among 159 patients. Additionally, ZUMA-1 data highlighted the benefits of prophylactic corticosteroids in managing patient safety without compromising treatment outcomes. Yescarta remains a pivotal therapy in treating difficult lymphomas.
Kite, a Gilead Company (Nasdaq: GILD), announced outcomes from two analyses of the ZUMA-7 trial for Yescarta, a CAR T-cell therapy for relapsed or refractory large B-cell lymphoma (r/r LBCL). Findings reveal 47% of patients needing subsequent therapy after second-line Yescarta compared to 71% for standard care. The study affirmed Yescarta's superiority in event-free survival (EFS) and progression-free survival (PFS), particularly for patients with varying metabolic tumor volumes. Yescarta's FDA approval in April 2022 and EMA's in October 2022 continue to underline its pivotal role in lymphoma treatment.
Kite, a Gilead company (Nasdaq: GILD), reported significant findings from a real-world analysis of Yescarta (axicabtagene ciloleucel) in treating relapsed or refractory large B-cell lymphoma (LBCL). The median 'vein-to-vein' time was 27 days, with a manufacturing time of 7 days and a total turnaround of 16 days. Shorter treatment times correlated with a 60% complete response rate. The analysis included 1,383 patients from 78 treatment centers. Data was presented at the 2022 ASH Annual Meeting.
Kite and Arcellx have announced a global collaboration to co-develop the CART-ddBCMA therapy for relapsed or refractory multiple myeloma. Kite will provide an upfront payment of $225 million and a $100 million equity investment. The companies will share development and commercialization costs, splitting U.S. profits 50/50. The partnership aims to address the significant unmet need in multiple myeloma treatment.
The transaction is expected to close in Q1 2023 and may reduce Gilead's EPS by approximately $0.16. The collaboration capitalizes on Kite's leadership in cell therapy and Arcellx's innovative approach.
Arcellx and Kite, a Gilead Company, have entered into a strategic collaboration to co-develop and commercialize CART-ddBCMA, a late-stage cell therapy for relapsed or refractory multiple myeloma. Arcellx will receive an upfront payment of $225M, a $100M equity investment, and potential contingent payments up to $3.9B. The companies will share U.S. profits 50/50 while Arcellx earns royalties on sales outside the U.S. The collaboration aims to accelerate patient access to innovative therapies.
ImmunoGen (Nasdaq: IMGN) has announced a clinical collaboration with Gilead Sciences (Nasdaq: GILD) to investigate the safety and anti-leukemia activity of pivekimab sunirine combined with magrolimab in patients with relapsed CD123-positive acute myeloid leukemia (AML). This partnership aims to explore the complementary mechanisms of action of both drugs. The new cohort, part of ImmunoGen's ongoing 802 study, will evaluate up to 42 patients with a focus on the complete response rate. Pivekimab is being developed for various hematologic malignancies and has received critical designations from regulatory bodies.
Marcus, a 36-year-old military veteran, was diagnosed with diffuse large B-cell lymphoma after noticing unusual growths. Although he achieved remission following six rounds of chemotherapy, the cancer returned aggressively, affecting his trigeminal nerve.
He was then referred to the University of Maryland Greenebaum Comprehensive Cancer Center, where he received CAR T-cell therapy. The initial PET CT scan revealed a dramatic response to the treatment. Grateful for the opportunity to spend precious time with his son, Marcus emphasized the importance of life and family.
Kite Pharma, a Gilead Company, and Daiichi Sankyo announced the transfer of marketing authorization for Yescarta (axicabtagene ciloleucel) in Japan to Gilead Sciences K.K. This follows a revision of their 2017 partnership agreement. Kite will manage sales and promotion activities in Japan post-transfer. The manufacturing facility in California is authorized to produce Yescarta for the Japanese market, with supply expected to start in early 2023. Currently, there are six hospitals in Japan approved to provide this CAR T-cell therapy.