MeiraGTx wins 3 Rare Pediatric designations and updates on AAV-AIPL1
Shares of US genetic meds company MeiraGTx Holdings (Nasdaq: MGTX) were up 7% at $7.12 in early trading after it announced important developments along with its third-quarter 2024 financials, reporting a $0.54 per share loss.
The company said that, following meetings with the UK Medicines and Healthcare products Regulatory Agency (MHRA), it intends to submit a Marketing Authorization Application under exceptional circumstances for AAV-AIPL1 in the UK without the need for further clinical studies.
MeiraGTx also revealed it is initiating discussions with the US Food and Drug Administration (FDA) around the potential for a similar pathway to approval in the USA.
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