MeiraGTx Q2 net loss narrows to $38.8M; FDA alignment on RIX pivotal study, RMAT for Parkinson's

MeiraGTx Holdings plc

2025-Q2 EPS reported -$0.99 vs consensus -$0.48 ▼ miss (-107.6%)

Net loss $38.8M ($0.48/sh) vs $48.6M ($0.76/sh) in Q2 2024; cash $32.2M at June 30, 2025.
FDA aligns on AAV-hAQP1 Phase 2 AQUAx2 as potentially pivotal for BLA in radiation-induced xerostomia; enrollment target Q4 2025, data late 2026.
FDA grants RMAT designation for AAV-GAD in Parkinson's; clean GCP inspection; Phase 3 study planned in 2025.
Received $23M of $200M from Hologen collaboration; forming JV Hologen Neuro AI with up to $230M funding for AAV-GAD development.
Preparing MAA in UK and BLA in US for AAV-AIPL1 in LCA4; Lancet publication shows all 11 treated children now able to see.

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