Audentes Therapeutics

Audentes’ AT342 Crigler-Najjar Syndrome NDA granted FDA clearance

Thursday, February 2, 2017

Audentes Therapeutics, a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, announced that the FDA has cleared the investigational new drug (IND) application for AT342, the company’s gene therapy product candidate to treat Crigler-Najjar Syndrome. The IND is now active and Audentes plans to initiate VALENS, the multicenter, multinational, open-label, ascending dose phase I/II clinical study of AT342. Preliminary data from VALENS is expected to be available by the end of 2017.

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