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Gain Therapeutics Clears FDA Hurdle for Parkinson’s Drug Trial

Shares of Gain Therapeutics jumped 21% to $2.40 following regulatory approval from the FDA to move into phase 2 clinical testing for its Parkinson’s disease candidate, GT-02287. The decision follows a series of successful phase 1 trials conducted in Australia that demonstrated the drug's safety and biological activity.

Gain Therapeutics Clears FDA Hurdle for Parkinson’s Drug Trial

The company plans to initiate the next stage of development during the third quarter of this year. This expanded study will incorporate existing research sites in Australia while integrating new clinical locations across the United States and Europe. Chief Executive Officer Gene Mack described the authorization as a validation of the extensive preclinical and clinical data amassed to date, marking a critical transition point for the biotechnology firm’s lead pipeline asset.

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