By Elias Schisgall
The Food and Drug Administration authorized Gain Therapeutics' investigational new drug application for a Parkinson's disease treatment, clearing the way for the biotechnology company to launch a phase 2 trial for the drug.
The application for the drug, known as GT-02287, was approved after phase 1 studies in Australia showed positive activity and safety data, the company said Monday.
The phase 2 study is expected to begin in the third quarter and include the initial study sites in Australia as well as new sites in the U.S. and Europe, the company said.
"The FDA's decision is a significant milestone for Gain and we believe it validates the extensive preclinical and clinical work supporting further development of GT-02287," Chief Executive Officer Gene Mack said.
Shares of Gain surged 21%, to $2.40, in after-hours trading Monday.
Write to Elias Schisgall at elias.schisgall@wsj.com