FDA extends review timeline of Beren’s adrabetadex NDA

Beren Therapeutics announced that the US Food and Drug Administration (FDA) has extended by three months the review timeline of its New Drug Application (NDA) for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C (I-NPC). The new Prescription Drug User Fee Act (PDUFA) target action date is November 17, 2026.

The extension follows Beren’s March 18, 2026 response to an FDA information request that included updates and clarifications to existing data and supporting documentation. The FDA classified the response as a Major Amendment to the NDA, which under FDA regulations extends the review period by three months.