Gain Therapeutics, Inc. has received authorization from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for GT-02287. This approval allows the company to initiate Phase 2 clinical development of GT-02287 for Parkinson's disease, with or without a GBA1 mutation, in the United States. Phase 1a and Phase 1b studies were conducted in Australia, and these sites are expected to continue participation in the Phase 2 study. New clinical sites in the U.S. and select European centers will also be added for the Phase 2 study. The initiation of the Phase 2 study is anticipated during the third quarter of 2026. The planned Phase 2a study will evaluate oral GT-02287 in participants with early Parkinson's disease, both treated and untreated, across the U.S., Australia, and Europe.