D. Western Therapeutics Institute, Inc.
Domestic development plan for the glaucoma treatment agent H-1337 announced
Decision on domestically focused development plan for H-1337. Initiate Japanese clinical trials in a phased manner, aiming to finalize small-scale dose confirmation in 2027 and commence domestic Phase III trials in 2029. Late-stage II trials in the United States continue. Plan to conduct a clinical trial consultation with PMDA by FY2026. No change to full-year earnings guidance for the fiscal year ending 2026.
Key Figures
- H-1337 domestic development plan decided
- Domestic Phase III trial: planned to start in 2029
- Clinical trial consultation with PMDA to be conducted within FY2026
AI要約
Section Heading
Declaration of the domestic development plan for the glaucoma treatment H-1337 and the roadmap for future clinical development. Late-stage II trials in the United States will continue. Development in Japan will commence with small-scale dose-confirmation trials in a Japanese-centric Asian population, then transition to a domestic Phase III trial. Policy to minimize trial costs and risks while maximizing the use of overseas data. Clinical trial consultations with PMDA are planned within FY2026. No change to the full-year earnings forecast for the fiscal year ending 2026 at present.
Section 2 Heading
Updates to the matters concerning the business plan and growth potential may affect future earnings forecasts, but there is no change to current full-year outlook. Depending on progress in clinical development, the timing of monetization could be delayed or accelerated. Through discussions with the partner Senju Pharmaceutical, we will optimize the priority and cost efficiency of domestic development.
D. Western Therapeutics Institute, Inc.
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