MeiraGTx Secures RMAT Designation from FDA for AAV-GAD in Parkinson's Treatment, Aligns with FDA on Phase 2 Study for Radiation-Induced Xerostomia

Reuters
08/14
MeiraGTx Secures RMAT Designation from FDA for AAV-GAD in Parkinson's Treatment, Aligns with FDA on Phase 2 Study for Radiation-Induced Xerostomia

MeiraGTx Holdings plc, a clinical-stage genetic medicines company, announced significant progress in its regulatory efforts during the second quarter of 2025. The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for MeiraGTx's AAV-GAD, aimed at treating Parkinson's disease. This designation is an important step towards expedited development and approval. In addition, MeiraGTx, in collaboration with Hologen, has made strides in their joint venture, Hologen Neuro AI Ltd. The collaboration involves a significant financial backing, with MeiraGTx receiving $23 million out of a $200 million cash consideration post-FDI clearance, and further committed funding of up to $230 million from Hologen. This joint venture aims to advance the development and commercialization of the AAV-GAD program and other CNS therapies.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. MeiraGTx Holdings plc published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9512593-en) on August 14, 2025, and is solely responsible for the information contained therein.

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