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.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.