MeiraGTx: FDA Grants Regenerative Medicine Advanced Therapy Designation To AAV-GAD

(RTTNews) - MeiraGTx Holdings plc (MGTX) announced that the FDA has granted Regenerative Medicine Advanced Therapy designation to AAV-GAD for the treatment of Parkinsons disease not adequately controlled with anti-Parkinsonian medications. The RMAT was awarded following the presentation to the FDA of positive data from 3 clinical studies.

The company noted that RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review.

For More Such Health News, visit rttnews.com.