FDA accepts sNDA and grants priority review to Aqneursa for ataxia-telangiectasia

IntraBio

19 May 2026 - IntraBio today announced that the US FDA has accepted for review its supplemental new drug application for Aqneursa (levacetylleucine) for the treatment of ataxia-telangiectasia in adults and paediatric patients.

The FDA simultaneously granted priority review and assigned a PDUFA target action date of 19 September 2026.

Read IntraBio press release

Michael Wonder

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Michael Wonder