MeiraGTx Reports Q1 Results and $430M Collaboration

By Philip Seaworth • Tuesday, May 13 15:20 • Permanent Link

MeiraGTx Holdings PLC (NASDAQ: MGTX) has reported its financial and operational results for the first quarter ending March 31, 2025. The company has engaged in a strategic collaboration with Hologen AI, which includes a $200 million upfront payment to MeiraGTx and the formation of a joint venture, Hologen Neuro AI Ltd, with a further $230 million in committed capital initially focusing on expediting phase 3 clinical development of AAV-GAD for Parkinson’s disease.

In terms of regulatory developments, the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson’s disease. This designation was based on positive data from three clinical studies, including two double-blind, sham-controlled studies. MeiraGTx has gained alignment with the FDA on the ongoing phase 2 Aquax2 randomized double-blind, placebo-controlled pivotal study in grade 2/3 radiation-induced xerostomia (RIX) to support a potential Biologics License Application (BLA) filing.

The efficacy data of rAAV8.hRKp.AIPL1 for the treatment of AIPL1-related retinal dystrophy, or LCA4, have been published in The Lancet, demonstrating meaningful responses in all 11 LCA4 children treated. The company is preparing the submission of a Marketing Authorization Application (MAA) under exceptional circumstances with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and is in discussions with the FDA for a potentially similar pathway to approval in the US.

MeiraGTx has also made progress in its manufacturing capabilities. The company's UK manufacturing facility holds authorizations issued by the MHRA, including an MIA(IMP) license authorizing the manufacturing, fill-finish, and QC testing of investigational medicinal products (IMPs) and a specials license.

The market has reacted to these announcements by moving the company's shares 3.69% to a price of $5.62. For more information, read the company's full 8-K submission here.

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