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 discontinuation of global development for zandelisib, targeting B-cell malignancies, outside Japan after receiving recent FDA guidance. MEI Pharma cited the inability to complete clinical development within a feasible timeframe for further investment as the reason. Although disappointed, Kyowa Kirin will continue clinical trials in Japan and consider regulatory submissions based on the Phase 2 MIRAGE and TIDAL studies. The decision does not relate to clinical data generated to date but reflects regulatory challenges.
Kyowa Kirin, in collaboration with the Davis Phinney Foundation and PMD Alliance, has released findings from the 2022 Parkinson's Care Partner Survey, emphasizing the growing role of care partners as Parkinson's disease affects 10 million globally, nearly 1 million in the U.S. The associated whitepaper, titled Burden and Benefit, explores the complexities of caregiving, highlighting that 93% of partners prioritize emotional support, while 73% struggle with watching loved ones' symptoms worsen. The study aims to enhance understanding and support for care partners, advocating for their well-being alongside their loved ones.
MEI Pharma and Kyowa Kirin have announced the presentation of three abstracts related to zandelisib, a PI3Kδ inhibitor for B-cell malignancies, at the American Society of Hematology Annual Meeting on December 10-13, 2022. The presentations will cover the efficacy and safety of zandelisib, both as a standalone treatment and in combination with zanubrutinib, along with immune-related toxicities. These findings may support ongoing clinical trials and potential marketing approvals globally.
Ardelyx, Inc. announced that its partner, Kyowa Kirin, has submitted a New Drug Application (NDA) to the Japanese Ministry of Health for tenapanor, aimed at treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. This submission triggers $35 million in milestone payments for Ardelyx. The NDA is underpinned by data from four Phase 3 trials demonstrating tenapanor's efficacy in lowering serum phosphorus levels. In the U.S., Ardelyx continues to pursue approval for tenapanor, branded as XPHOZAH, with a review scheduled for November 16, 2022.
MEI Pharma (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. have published Phase 1b clinical study results for zandelisib, a PI3Kδ inhibitor, in The Lancet Oncology. The study showed that an intermittent dosing schedule of zandelisib resulted in a lower risk of significant adverse events than a continuous regimen, without sacrificing efficacy. Out of 97 patients evaluated, the intermittent group exhibited a 20% incidence of Grade 3 or worse adverse events compared to 45% in the continuous group. These results support further Phase 2 and Phase 3 studies for zandelisib in patients with B-cell malignancies.
MEI Pharma announced promising data from the zandelisib clinical development program presented at the 2022 European Hematology Association Hybrid Congress. The Phase 2 TIDAL study reported a 70.3% objective response rate and a 35.2% complete response rate in patients with relapsed or refractory follicular lymphoma. Notably, 87.5% of responses occurred within the first two therapy cycles. Adverse events led to a 9.9% discontinuation rate, primarily consisting of Grade 3 AEs. The study aims to continue assessing zandelisib's safety and efficacy as enrollment progresses in additional cohorts.
MEI Pharma and Kyowa Kirin presented data from the ongoing Phase 2 TIDAL study on zandelisib at the ASCO 2022 Annual Meeting. The study showed a 70.3% objective response rate and a 35.2% complete response rate among patients with relapsed or refractory follicular lymphoma. Notably, 87.5% of responses occurred within the first two cycles of therapy. Safety data indicated that 9.9% of patients discontinued for drug-related adverse events, with 83% reporting Grade 3 adverse events primarily in initial treatment cycles. The results support the continued development of zandelisib, particularly in the Phase 3 COASTAL study.
MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. announced the presentation of Phase 2 TIDAL study data on zandelisib at the ASCO 2022 Annual Meeting, scheduled for June 3-7, 2022. The study evaluates the efficacy and safety of zandelisib, a PI3Kδ inhibitor for treating B-cell malignancies. The abstract ID is 7511, with a poster discussion led by Dr. Andrew David Zelenetz on June 4. MEI Pharma focuses on developing innovative cancer therapies, aiming for FDA approvals for its clinical-stage assets.
LUCA Science and Kyowa Kirin have announced a research collaboration to develop innovative treatments for mitochondrial diseases using LUCA's proprietary mitochondrial therapy platform. Mitochondrial diseases, affecting organs with high energy needs, currently have no definitive cures, only symptomatic treatments. This partnership aims to leverage Kyowa Kirin's drug discovery expertise with LUCA's technology to address the unmet medical needs in mitochondrial therapeutics, as highlighted by both companies’ executives.
MEI Pharma (NASDAQ: MEIP) and Kyowa Kirin (Tokyo: 4151) announced that two abstracts regarding zandelisib, a PI3Kδ inhibitor for B-cell malignancies, will be presented at the European Hematology Association (EHA) 2022 Hybrid Congress from June 9-17, 2022. Oral presentation on June 11 will focus on the efficacy and safety of zandelisib in relapsed or refractory follicular lymphoma, while a poster on June 10 will discuss results from a multi-arm Phase 1b study. These presentations may support future FDA marketing approvals.