【Nexera Pharma】Korean Regulatory Designation Acquisition and New Drug Development | June 2026

Financial Results Overview

Nexera Pharma has obtained designation as a rare disease drug (ODD) and priority review system (GIFT) from Korea’s MFDS, announcing plans to submit an approval application for DMD treatment drug vamorolone within 2026. Long-term safety data has also been published, indicating low incidences of vertebral fractures and cataracts. This is expected to facilitate early access for Korean DMD patients and enhance the company's medium- to long-term value.

Future Outlook and Corporate Activities

Through obtaining regulatory designations, the company aims to promote early access to innovative treatments in Korea and improve long-term business revenue and corporate value. In preparation for the 2026 approval application, the company will work closely with regulatory authorities while advancing clinical and regulatory processes. Moving forward, we will continue to develop new drugs in the rare disease field and expand globally, prioritizing meeting unmet needs of patients.