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 said.
Shares were 7% higher in recent trading on Friday.
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