MeiraGTx Holdings PLC (NASDAQ: MGTX) has reported its financial and operational results for the second quarter ended June 30, 2025. The company is making significant progress in its late-stage clinical programs and regulatory interactions.
The company has gained alignment with the U.S. Food and Drug Administration (FDA) on the ongoing phase 2 AQUA2 randomized double-blind, placebo-controlled pivotal study in grade 2/3 radiation-induced xerostomia (RIX) to potentially support a Biologics License Application (BLA) filing. The study is on track for potential data readout late in 2026.
MeiraGTx received Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson’s disease. The company is also on track to file for Marketing Authorization Approval (MAA) under exceptional circumstances with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of LCA4, and BLA in the U.S. with the FDA via a similar pathway to approval in the fourth quarter of 2025.
In terms of financials, MeiraGTx had cash and cash equivalents of approximately $32.2 million as of June 30, 2025, with receivables due from Johnson & Johnson Innovative Medicine and tax incentive receivables. The company anticipates having sufficient capital to fund operating expenses and capital expenditure requirements into 2027 and to repay its debt obligation of $75.0 million to Perceptive Credit Holdings III, LP (due in August 2026).
The company has received $23 million of the $200 million in cash consideration due post-Foreign Direct Investment (FDI) clearance, with the remainder expected in the third quarter of 2025. MeiraGTx is forming a joint venture, HoloGen Neuro AI Ltd, with additional committed funding from HoloGen of up to $230 million into the joint venture to finance the development of the AAV-GAD program in Parkinson’s disease to commercialization, as well as other locally-delivered therapies to the central nervous system. MeiraGTx will hold a 30% ownership in the joint venture and lead all clinical development and manufacturing.
In addition, the company has made progress with its riboswitch technology platform, with an initial focus on obesity and metabolic disease, neuropathic pain, and CAR-T. MeiraGTx continues to advance its manufacturing capabilities, with successful renewals of authorizations and licenses for its facilities in the United Kingdom and Ireland.
These developments indicate MeiraGTx's commitment to advancing its clinical programs and leveraging partnerships to drive innovation in genetic medicines. As a result of these announcements, the company's shares have moved 3.99% on the market, and are now trading at a price of $8.34. For the full picture, make sure to review MeiraGTx's 8-K report.
