MeiraGTx secures MHRA pathway for AAV-AIPL1 approval without further studies; Q3 net loss $39.3M

MeiraGTx Holdings plc

2024-Q3 EPS reported -$1.62 revenue$11,889,000

AAV-AIPL1 MAA under exceptional circumstances agreed with MHRA; no further clinical studies required for UK approval.
11 blind children treated with AAV-AIPL1 all gained vision within 4+ weeks; FDA discussions initiated for similar US pathway.
AAV-GAD bridging study met safety endpoint; 18-point improvement in UPDRS Part 3 'off' score (p=0.03) at Week 26.
Three FDA Rare Pediatric Disease Designations awarded for AIPL1, BBS10, and RDH12 programs.
Cash $122.9M + $3.3M receivables; net loss $39.3M ($0.55 per share) vs $44.3M ($0.74) YoY.

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