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.
Amgen (NASDAQ: AMGN) and Kyowa Kirin have announced positive top-line results from their Phase 3 ASCEND long-term extension study of rocatinlimab for moderate to severe atopic dermatitis. The study, involving approximately 2,600 patients, evaluated the drug's safety and efficacy over an additional 32 weeks following initial 24-week therapy.
Key findings include a favorable safety profile with low discontinuation rates and less than 1 per 100 patient-years incidence of gastrointestinal ulceration events. The majority of patients who continued rocatinlimab monotherapy, administered every 4 or 8 weeks, demonstrated sustained therapeutic benefits at one year across multiple measures including skin clearance, itch reduction, and disease control.
Kyowa Kirin (OTC:KYKOY) announced that results from their Phase 3 ROCKET IGNITE trial of rocatinlimab will be presented at the EADV 2025 Annual Meeting in Paris. The investigational therapy targets the OX40 receptor in patients with moderate-to-severe atopic dermatitis.
The presentation will be delivered by Dr. Emma Guttman-Yassky on September 19th at 4:40 PM CEST. The study focuses on rocatinlimab's efficacy and safety in treating atopic dermatitis, a chronic inflammatory disease characterized by skin redness, pruritus, and pain.
Kyowa Kirin (TSE: 4151) and La Jolla Institute for Immunology (LJI) have renewed their 35-year research partnership for another three years. The collaboration, which began in 1988, combines LJI's academic expertise with Kyowa Kirin's drug development capabilities.
The partnership has led to significant discoveries in immunology and supported first-in-class therapies for rare diseases. Notable developments include an immunotherapy for moderate to severe atopic dermatitis currently in Phase III clinical trials. Kyowa Kirin currently markets three therapies in North America and over 50 products worldwide in areas including hematology-oncology and rare bone disease.
The renewed agreement provides LJI with research funding, faculty hiring support, and project-specific research funds. The partnership's new focus will be on developing cell and gene therapies for diseases with or no treatment options, with preliminary data expected in 2025 for various conditions including ulcerative colitis, acute respiratory distress, and atopic dermatitis.
Amgen (NASDAQ: AMGN) and Kyowa Kirin announced positive results from the ROCKET Phase 3 clinical program for rocatinlimab, their investigational therapy for moderate to severe atopic dermatitis. The IGNITE study, involving 769 adults, met all primary and secondary endpoints with statistical significance across two dose strengths.
Key results at week 24 for the higher dose group showed:
- 42.3% of patients achieved EASI-75 (29.5% difference vs placebo)
- 23.6% achieved vIGA-AD score of 0/1 (14.9% difference vs placebo)
- 22.7% achieved rIGA score of 0/1 (14.4% difference vs placebo)
The SHUTTLE study, testing rocatinlimab with topical treatments in 746 adults, also met its endpoints. Common side effects included pyrexia, chills, and headache, with gastrointestinal ulceration events occurring in less than 1% of patients. Additional studies ASCEND, ASTRO, and ORBIT are ongoing to evaluate long-term maintenance and effects in adolescent patients.
Kyowa Kirin (TSE: 4151) announced that results from their Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy for moderate-to-severe atopic dermatitis (AD), will be presented at the American Academy of Dermatology Annual Meeting 2025 in Orlando.
The ROCKET HORIZON trial is a Phase 3, randomized, placebo-controlled study involving 726 adult patients. Participants received either rocatinlimab or placebo via subcutaneous injection every four weeks for 24 weeks, with a loading dose at week two. The trial's co-primary endpoints focus on achieving specific scores in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and Eczema Area and Severity Index (EASI-75) at week 24.
Rocatinlimab targets the OX40 receptor (OX40R), addressing T-cell imbalance, a root cause of inflammatory diseases including AD. The ROCKET Phase 3 program comprises eight studies evaluating rocatinlimab's safety and efficacy across multiple dosing regimens in adults and adolescents with moderate to severe AD.
Kura Oncology and Kyowa Kirin have announced a global strategic collaboration for developing and commercializing ziftomenib, a selective oral menin inhibitor for acute myeloid leukemia (AML) treatment. Kura will receive a $330 million upfront payment and up to $1.2 billion in milestone payments. The companies will share 50/50 profits in the U.S., with Kura leading U.S. operations and Kyowa Kirin having exclusive rights outside the U.S. The collaboration includes development for frontline indications and combination therapies. Kura expects to submit a New Drug Application in 2025 and estimates a U.S. market opportunity of up to $3 billion annually in the frontline setting.
Kyowa Kirin announced positive top-line results from the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy for moderate to severe atopic dermatitis. The trial met its co-primary endpoints:
1. 19.3% of rocatinlimab patients achieved vIGA-AD™ 0/1 with ≥2-point reduction from baseline vs 6.6% for placebo (p<0.001)
2. 32.8% of rocatinlimab patients achieved EASI-75 vs 13.7% for placebo (p<0.001)
The trial also met all key secondary endpoints, including measures of skin clearance, pruritus, and quality of life. Safety findings were comparable to the Phase 2b study. HORIZON is the first of eight Phase 3 trials in the ROCKET program, involving 726 adult patients over 24 weeks.
Kyowa Kirin (TSE:4151) will present new research on X-linked hypophosphatemia (XLH) at the American Society for Bone and Mineral Research (ASBMR) 2024 annual meeting. The presentations include one oral and nine posters focusing on:
1. Real-world impact of burosumab treatment in XLH patients
2. XLH burden on patients' lives
3. Bridging evidence gaps for improved clinical decision-making
Key highlights include patient-reported outcomes from a UK study, effectiveness of burosumab versus conventional therapy, and biochemical measurements in burosumab-treated patients. The research aims to enhance understanding of XLH management and improve patient care. The ASBMR meeting takes place September 27-30 in Toronto.
Kyowa Kirin's XLH Disease Monitoring Program (DMP) has revealed significant employment challenges for adults with X-linked Hypophosphatemia (XLH). The study, published in JBMR Plus, shows that 31% of working-age adults with XLH were unemployed, a rate 8 times higher than the US general population. Among those employed, 60% worked in light or sedentary roles. The analysis also found that individuals with more past orthopedic surgeries and worse physical function were less likely to be employed.
These findings highlight the substantial burden of XLH on patients' lives, particularly in the workplace. The DMP, a 10-year observational study, aims to advance understanding of XLH through real-world research. Additional findings will be presented at the American Society for Bone and Mineral Research annual meeting in Toronto, September 27-30.
Kyowa Kirin (TSE: 4151) has announced the discontinuation of Fareston (toremefine) 60 mg tablets distribution in the United States, effective August 31, 2024. This decision aligns with the company's Vision for 2030, focusing on novel therapies. The last order date is set for August 29, 2024, at 2:00 pm CT. Kyowa Kirin has notified the FDA and Orion , the manufacturer of toremefine tablets, about this change. For inquiries, stakeholders can contact specialty.channel.us@kyowakirin.com.