Kyowa Hakko - KYKOY STOCK NEWS

Kyowa Kirin has appointed Steve Schaefer as the new President of North America, effective April 11, 2023. Schaefer joins from Takeda where he held senior roles, including Senior Vice President of the Neuroscience Business Unit. With over 25 years of experience in the pharmaceutical sector, he has been integral in managing multi-billion dollar commercial portfolios and is known for his expertise in advanced analytics and sales operations.

Schaefer succeeds Gary Zieziula, who is retiring after leading the company through significant growth since April 2020. Under Zieziula's leadership, Kyowa Kirin North America has become the fastest-growing region for the company, contributing over a quarter of global revenues. The transition aims to further enhance Kyowa Kirin's innovative therapies across North America.

Kyowa Kirin Co., Ltd. announces the presentation of Phase 2b study data for rocatinlimab (KHK4083/AMG 451) at the American Academy of Dermatology 2023 Annual Meeting from March 17-22 in New Orleans. The trial involved 274 patients with moderate-to-severe atopic dermatitis, demonstrating significant reductions in serum IgE concentrations and improvements in patient-reported outcomes. Rocatinlimab's IgE reductions were maintained to Week 56. The study's adverse events were similar across groups, with no serious complications reported. Collaborative efforts with Amgen are also highlighted to further develop this potential treatment.

Kyowa Kirin Co., Ltd. announced the presentation of data from its Phase 2b study of rocatinlimab at the American Academy of Dermatology 2023 Annual Meeting on March 17-21 in New Orleans. Rocatinlimab, an investigational anti-OX40 monoclonal antibody, aims to treat moderate-to-severe atopic dermatitis, which affects approximately 15-20% of children and 10% of adults globally. Two posters will be presented, focusing on its efficacy and the reduction of IgE concentrations. Kyowa Kirin has partnered with Amgen for the development and commercialization of rocatinlimab globally, except in Japan, where it retains rights.

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.