Domestic Phase 3 Clinical Trial for Treatment of Achondroplasia (umedaptanib pegol): Expansion of Participating Medical Institutions Completed (planned number of facilities reached)

Section Heading

This release is IR information reporting the expansion of the clinical trial conduct framework for umedaptanib pegol, a treatment for achondroplasia, in the domestic Phase 3 trial. Six additional facilities have obtained approval from the Institutional Review Board (IRB), bringing the total number of implementing medical institutions to 16, thereby strengthening the enrollment acceleration foundation. Consequently, the planned system setup has been completed as scheduled, and accelerated progress is expected going forward. It is stated that there will be no impact on the full-year results for the fiscal year ending March 2027.

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Umedaptanib pegol is an aptamer that inhibits FGF2, and development of a new drug that directly acts on the pathogenesis of achondroplasia is progressing. It has been designated as a drug for rare diseases, offering a long-term treatment option. The expansion of the trial framework is an important milestone to accelerate subject enrollment, and future trial progress along with safety and efficacy data will be of interest to investors.