Kyowa Hakko Stock Price, News & Analysis

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.