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Gain Therapeutics Gets US FDA Approval to Advance GT-02287 Into Phase 2 Study for Parkinson's Disease

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Gain Therapeutics (GANX) said Monday the US Food and Drug Administration has authorized investigational new drug application for its lead drug candidate GT-02287.

The move will allow the start of the phase 2 clinical development of GT-02287 to treat Parkinson's disease with or without a GBA1 mutation in the US, the company said.

A planned phase 2a study of oral GT-02287 in treated and untreated people with early Parkinson's disease is expected to enroll participants in the US, Australia, and Europe, the company said, adding it expects initiation of phase 2a in Q3.

The company's shares were up 20% in after-hours activity.

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