Welcome to our dedicated page for Kyowa Hakko news (Ticker: KYKOY), a resource for investors and traders seeking the latest updates and insights on Kyowa Hakko stock.
News for KYOWA HAKKO KOGY UNSP/ADR (KYKOY) centers on announcements from Kyowa Kirin Co., Ltd., a Japan-based global specialty pharmaceutical company. Recent releases highlight clinical trial milestones, scientific presentations, strategic collaborations and portfolio decisions across the company’s focus areas in immunology, hematology-oncology, bone and mineral disorders, and rare diseases.
A major theme in Kyowa Kirin’s news flow is the development of rocatinlimab, an investigational anti-OX40 human monoclonal antibody described as a potential T-cell rebalancing therapy for moderate to severe atopic dermatitis. Updates include top-line results from Phase 3 ROCKET trials such as HORIZON, IGNITE and the long-term ASCEND extension, as well as planned presentations at major dermatology congresses. These articles detail efficacy endpoints like EASI-75 and Investigator Global Assessment scores, safety findings and long-term maintenance data.
Another recurring topic is Kyowa Kirin’s work in hematology and hemato-oncology. News includes a global strategic collaboration with Kura Oncology to develop and commercialize ziftomenib, a selective oral menin inhibitor in development for acute myeloid leukemia and other hematologic malignancies. Releases describe how responsibilities are shared between the companies in the United States and other regions.
Kyowa Kirin also reports extensively on X-linked hypophosphatemia (XLH), sharing real-world evidence from the XLH Disease Monitoring Program and new analyses of disease burden, work productivity and treatment outcomes. Additional items cover presentations on burosumab (CRYSVITA) and XLH at scientific meetings, as well as updates on a long-standing research alliance with La Jolla Institute for Immunology and the decision to end distribution of Fareston (toremifene) tablets in the United States.
Investors and observers can use this news stream to follow Kyowa Kirin’s disclosed clinical progress, research partnerships and portfolio focus as they relate to the KYKOY ADR.
MEI Pharma and Kyowa Kirin announced the dosing of the first patient in the Phase 3 COASTAL study, evaluating zandelisib, a selective PI3Kδ inhibitor, alongside rituximab for relapsed or refractory follicular and marginal zone lymphomas. This study aims to enroll 534 patients and will compare zandelisib plus rituximab to standard chemotherapy. The primary endpoint is progression-free survival, with the results intended to support marketing applications for zandelisib in the U.S. and globally.
On July 22, 2021, Kyowa Kirin announced promising results from the MAVORIC trial for POTELIGEO (mogamulizumab-kpkc) in treating mycosis fungoides (MF) and Sézary syndrome (SS). The study revealed significantly improved outcomes for patients with higher blood involvement, with progression-free survival of 7.7 months for mogamulizumab versus 3.1 months for vorinostat (P<0.0001). The overall response rate was 28.0% for mogamulizumab compared to 4.8% for vorinostat. This analysis underscores the importance of monitoring blood involvement to optimize treatment strategies.
MEI Pharma and Kyowa Kirin have initiated the second arm of the global Phase 2 TIDAL study, dosing the first patient with relapsed or refractory marginal zone lymphoma. This arm evaluates zandelisib, a PI3K delta inhibitor, alongside a previous arm focusing on follicular lymphoma. Both arms aim for separate FDA accelerated approval applications. The study will assess objective response rates and tolerability of zandelisib. This collaboration between the companies highlights their commitment to advancing therapeutic options for patients with B-cell malignancies.
Amgen and Kyowa Kirin have announced a global collaboration to jointly develop KHK4083, a potential first-in-class treatment for moderate-to-severe atopic dermatitis. Amgen will lead the development and commercialization worldwide, except in Japan, where Kyowa Kirin retains rights. The agreement includes a $400 million upfront payment from Amgen and additional milestone payments up to $850 million. KHK4083 has shown promising Phase 2 results, significantly improving symptoms in patients. The partnership builds on a long history of collaboration, leveraging Amgen's expertise and Kyowa Kirin's innovative technology.
On May 19, 2021, MEI Pharma announced promising data for zandelisib, a PI3Kδ inhibitor, aimed at treating B-cell malignancies. Key findings include an 87% overall response rate in relapsed or refractory follicular lymphoma patients, with 93% in non-POD24 patients. The Phase 3 COASTAL study, comparing zandelisib plus rituximab to standard chemotherapy in indolent non-Hodgkin's lymphoma, is set to enroll 534 patients. Topline results from the ongoing Phase 2 TIDAL study are expected later this year, reinforcing the commitment to zandelisib's development as a potential best-in-class therapy.
MEI Pharma and Kyowa Kirin have announced updated clinical data from a Phase 1b study of zandelisib, a selective PI3Kδ inhibitor, in combination with zanubrutinib, for patients with relapsed or refractory B-cell malignancies. This data will be presented at the European Hematology Association (EHA) 2021 Virtual Congress from June 9-17, 2021. The study aims to assess the drug combination's tolerability and efficacy, potentially leading to improved therapeutic options for patients. The abstract is accessible on the EHA website.
Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd., has appointed Ernesto Aycardi, M.D., as Chief Development Officer and Eslie Dennis, M.D., MBChB, FCP(SA) as Chief Medical Officer. These roles are pivotal as the company aims to advance its pipeline products, including KW-6356 and KHK4083, and collaborate with MEI Pharma on zandelisib. The leadership team expansion reflects the company's commitment to scientific innovation and patient care. Both appointees bring extensive pharmaceutical expertise, crucial for the company's growth trajectory in North America.
Ardelyx, Inc. (Nasdaq: ARDX) announced that its partner Kyowa Kirin has begun four Phase 3 clinical trials in Japan for tenapanor, aimed at treating hyperphosphatemia. This milestone triggers a $5 million payment to Ardelyx. The trials include various study designs assessing tenapanor's effectiveness in patients with chronic kidney disease (CKD) on dialysis. Ardelyx is expecting a PDUFA date on April 29, 2021, for tenapanor's review by the FDA. The collaboration could yield up to $55 million in total development milestones and significant sales royalties.
MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. have completed enrollment in the follicular lymphoma primary efficacy population for the global Phase 2 TIDAL study. This study evaluates zandelisib, a potential cancer treatment. The primary efficacy population includes 91 patients with follicular lymphoma and 64 with marginal zone lymphoma. Topline data is expected in Q4 2021, with plans to submit for FDA accelerated approval. Zandelisib holds Fast Track designation for adult patients with relapsed follicular lymphoma who have undergone at least two prior systemic therapies.
Kyowa Kirin, Inc. announces the merger of its research and development divisions into a streamlined entity, effective April 1, 2021. This initiative aims to enhance productivity and collaboration across North America, contributing to the company's growth and alignment with its New 2030 Vision. Since 2017, annual revenues from KKNA medicines have surged from $25M to over $500M. Key organizational changes include leadership promotions and plans to file for mogamulizumab approval in Canada in 2021, reflecting a commitment to addressing patient needs through innovative specialty medicines.