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.
La Jolla Institute for Immunology and Kyowa Kirin, Inc. have renewed their collaboration through a three-year agreement, enhancing their longstanding partnership. The new funding will increase annual support for research projects, emphasizing human translational potential and faculty recruitment. Kyowa Kirin will have first rights to negotiate licenses for discoveries resulting from the funded projects. This collaboration aims to fuse Kyowa Kirin's drug development capabilities with LJI's immunology expertise to accelerate the introduction of new therapies.
Cumberland Pharmaceuticals (NASDAQ: CPIX) has acquired SANCUSO® (granisetron transdermal patch) from Kyowa Kirin for $13.5 million, with additional milestone payments and royalties up to 10% on U.S. net sales. SANCUSO is the only FDA-approved patch for preventing chemotherapy-induced nausea and vomiting, with U.S. sales exceeding $14 million in 2020. This acquisition allows Cumberland to enhance its oncology portfolio, addressing the needs of the approximately 500,000 Americans undergoing chemotherapy each year.
Amgen and Kyowa Kirin announced positive Phase 2 study results of AMG 451/KHK4083 for treating moderate-to-severe atopic dermatitis, presented at EADV 2021. The study, involving 274 patients, met its primary endpoint with significant improvements in Eczema Area and Severity Index (EASI) scores across all treatment groups compared to placebo. Key secondary endpoints also showed positive outcomes. Adverse events were generally mild. Future Phase 3 trials are anticipated to further validate these promising findings, with potential implications for over 30 million affected individuals.
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.