Kyowa Hakko Stock Price, News & Analysis

Kyowa Kirin and Amgen announced positive results from a Phase 2 study of KHK4083/AMG 451 for moderate-to-severe atopic dermatitis, presented at the EADV Congress on Oct. 2, 2021. The study met its primary objective, demonstrating statistically significant improvements in Eczema Area and Severity Index (EASI) scores at 16 weeks across all treatment groups compared to placebo. Patients continued to show efficacy improvements beyond 16 weeks, with common adverse events being mild to moderate. Phase 3 trials are expected to begin in the first half of 2022.

Kyowa Kirin, a global specialty pharmaceutical company, appointed Paula Soteropoulos as a non-executive Director on its North America Board, effective September 1, 2021. Soteropoulos, with over 30 years in drug development and global commercialization, has held key roles at Ensoma, uniQure, and Akcea Therapeutics. Her expertise spans several therapeutic areas, particularly rare diseases. President Gary Zieziula highlighted her industry experience as a valuable asset for navigating growth opportunities.

Kyowa Kirin announced new data demonstrating the long-term benefits of CRYSVITA (burosumab) for adults with X-linked hypophosphataemia (XLH) after 96 weeks of therapy. The study, a randomized, double-blind, placebo-controlled phase 3 trial, showed significant improvements in pain, stiffness, fatigue, and physical function. Patients exhibited increased serum phosphorus levels and enhanced mobility as measured through PROs and the 6-minute walk test.

These results underscore Kyowa Kirin's commitment to addressing the needs of XLH patients.

Kyowa Kirin launched initiatives to enhance understanding of mycosis fungoides (MF) and Sézary syndrome (SS), both subtypes of cutaneous T-cell lymphoma (CTCL), focusing on the role of POTELIGEO (mogamulizumab-kpkc). The omni-channel campaign, Treat the Blood. Treat the Skin., aims to educate physicians on the significance of blood involvement in treatment decisions, with patient testimonials shared through various media. The launch aligns with Blood Cancer Awareness Month, emphasizing the importance of routine blood testing for improving patient outcomes in MF and SS.

Amgen (NASDAQ: AMGN) announced new data from its inflammation pipeline will be presented at the EADV 30th Congress from Sept. 29 to Oct. 2, 2021. Key highlights include late-breaking results from a Phase 2 study of AMG 451/KHK4083, a potential treatment for moderate-to-severe atopic dermatitis, and new data from the Phase 3 ADVANCE trial on Otezla's efficacy for plaque psoriasis. Amgen aims to share insights into innovative treatments for patients with severe skin conditions, reflecting its commitment to dermatologic diseases advancement.

Kyowa Kirin Co., Ltd. announced detailed data from a Phase 2 study of KHK4083/AMG 451, a potential first-in-class anti-OX40 monoclonal antibody for treating atopic dermatitis. The findings will be highlighted at the EADV Congress from September 29 to October 2, 2021. The study involved 274 patients, assessing its efficacy and safety through the Eczema Area and Severity Index (EASI) over 16 weeks. KHK4083/AMG 451 leverages advanced POTELLIGENT technology to enhance immune responses and is a collaborative development with Amgen, which will lead global commercialization outside of Japan.

Kyowa Kirin announced that it will present detailed data from the Phase 2 study of KHK4083/AMG 451, an anti-OX40 monoclonal antibody, at the European Academy of Dermatology and Venereology Congress from September 29 to October 2, 2021. This treatment targets moderate to severe atopic dermatitis, with implications for other autoimmune diseases. The study involved 274 patients and focused on the efficacy and safety of KHK4083/AMG 451, which utilizes Kyowa Kirin's advanced POTELLIGENT technology to enhance antibody activity. The presentation is scheduled for October 2, 2021.

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.