TOKYO, Apr 02 (Pulse News Wire) – RIBOMIC Inc. (4591.T) secured approval from the Pharmaceuticals and Medical Devices Agency (PMDA) for its Phase III clinical trial of umedaptanib pegol, an anti-FGF2 aptamer drug designed to treat achondroplasia.
The approval follows a submission made on March 18, 2026, which was based on multiple pre-submission consultations and written responses. The Phase III trial will involve 16 pediatric patients aged two to 14 years, receiving a weekly subcutaneous dose of 1 mg/kg without placebo or comparator drugs.
The primary endpoint is the change in annual height velocity (AHV) measured over 52 weeks compared to baseline observations. A positive outcome, defined as an AHV increase of more than 2 cm/year, would offer a new potent treatment option for children with achondroplasia.
The impact of this clinical trial on RIBOMIC's fiscal year ending March 2027 performance will be reflected in future earnings forecasts scheduled for release.
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