MGTX - MeiraGTx's AAV-CNGA3 Fast Track'd in U.S. for inherited retinal disease

The FDA grants Fast Track designation to MeiraGTx Holdings' (MGTX) AAV-CNGA3 gene therapy product candidate for the treatment of achromatopsia ((ACHM)) caused by mutations in the CNGA3 gene.Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application. ACHM is an inherited retinal disease that severely limits a person’s sight by preventing cone photoreceptors in the eye from functioning. MeiraGTx and Johnson & Johnson (JNJ) unit, Janssen Pharmaceuticals are jointly developing AAV-CNGA3.AAV-CNGA3 is an investigational gene therapy treatment designed to restore cone function, delivered to the cone receptors at the back of the eye via subretinal injection.Shares up 3% premarket.

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MeiraGTx's AAV-CNGA3 Fast Track'd in U.S. for inherited retinal disease