Kyowa Hakko - KYKOY STOCK NEWS

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.

Kyowa Kirin has announced board approval for a $530 million investment to build a new biologics manufacturing plant in Sanford, NC. This 171,700-square-foot facility will accelerate the production of new biologic therapies, especially for rare diseases, and create over 100 new jobs with an average salary of $91,496. The plant is expected to be operational by 2027 and will also contribute to the local economy. Supported by $10 million in state and local incentives over 12 years, the investment is projected to grow North Carolina's economy by $1.05 billion. The facility will be part of the Helix Innovation Park and will benefit from local biomanufacturing resources and specialized talent from nearby universities.

Kyowa Kirin Co., will present pre-clinical data at the Association for Research in Vision and Ophthalmology Annual Meeting 2024 regarding the use of nano-crystalized tivozanib eye drops for neovascular age-related macular degeneration (nAMD). The study showcases increased drug delivery efficiency to the retina/choroid compared to microcrystal formulations in animal models. This novel investigational agent has the potential to lessen the burden for patients with nAMD and diabetic macular edema (DME). Separate phase 2 clinical trials are ongoing to investigate the safety and efficacy of tivozanib eye drops in patients with nAMD and DME.