MeiraGTx Says FDA Granted RMAT Designation to AAV-GAD for Treating Parkinson's; Shares Up Pre-Bell-March 2024-www.financetom.com

MeiraGTx Says FDA Granted RMAT Designation to AAV-GAD for Treating Parkinson's; Shares Up Pre-Bell

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MeiraGTx Says FDA Granted RMAT Designation to AAV-GAD for Treating Parkinson's; Shares Up Pre-Bell

May 26, 2025 5:02 AM

08:25 AM EDT, 05/09/2025 (MT Newswires) -- MeiraGTx Holdings ( MGTX ) said Friday its investigational gene therapy AAV-GAD has received regenerative medicine advanced therapy designation from the US Food and Drug Administration for the treatment of Parkinson's disease.

The designation is for the treatment of Parkinson's disease not adequately controlled with anti-Parkinsonian medications, the company said.

The designation includes the benefits of fast track and breakthrough therapy designations with rolling review and potential priority review of a product's biologics license application, MeiraGTx ( MGTX ) said.

Shares were 7% higher in recent trading on Friday.

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