MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV-GAD for the Treatment of Parkinson’s Disease
MeiraGTx Holdings plc - Ordinary Shares (MGTX)
Company Research
Source: GlobeNewswire
- This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson’s disease - 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 LONDON and NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV-GAD for the treatment of Parkinson’s disease not adequately controlled with anti-Parkinsonian medications. This RMAT was awarded following the presentation to the FDA of positive data from 3 clinical studies demonstrating the benefit of AAV-GAD when administered in a one-time stereotactic infusion to the su
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MGTX
News
- MeiraGTx Holdings plc (NASDAQ: MGTX) had its price target lowered by analysts at Chardan Capital from $38.00 to $35.00. They now have a "buy" rating on the stock.MarketBeat
- MeiraGTx Announces the Presentation of Four Posters at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual MeetingGlobeNewswire
- MeiraGTx Reports First Quarter 2025 Financial and Operational Results [Yahoo! Finance]Yahoo! Finance
- MeiraGTx Reports First Quarter 2025 Financial and Operational ResultsGlobeNewswire
- Cone Rod Dystrophy Market Report 2025-2030, with Profiles of SparingVision, Beacon Therapeutics, Nanoscope Therapeutics, MeiraGTx, Ascidian Therapeutics, jCyte, BlueRock Therapeutics and more [Yahoo! Finance]Yahoo! Finance
MGTX
Earnings
- 5/13/25 - Miss
MGTX
Analyst Actions
- 5/14/25 - Chardan Capital
MGTX
Sec Filings
- 6/17/25 - Form 8-K
- 6/16/25 - Form 4
- 6/16/25 - Form 4
- MGTX's page on the SEC website