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.
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