Kyowa Hakko Stock Price, News & Analysis

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.

Kyowa Kirin announces successful Phase 2 study results for KHK4083, an anti-OX40 monoclonal antibody for treating moderate to severe atopic dermatitis. The trial met primary endpoints, showing significant improvement in the Eczema Area and Severity Index (EASI) at 16 weeks compared to placebo. Conducted in multiple countries with 274 patients, the study demonstrated ongoing efficacy beyond the initial 16 weeks. Common adverse events were reported, but no fatalities occurred. The company looks forward to sharing comprehensive results in future publications and presentations.

Kyowa Kirin and MEI Pharma announced that the first patient has been dosed in a pivotal Phase 2 study of zandelisib in Japan. This multicenter, open-label trial aims to evaluate zandelisib as a monotherapy for patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma (iNHL). In partnership, both companies seek to expand zandelisib's global development, with Kyowa Kirin holding exclusive rights outside the U.S. The study will include 60 patients, primarily measuring the objective response rate, and is expected to conclude by September 2024.