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February 24, 2026

FDA accepts Beren Therapeutics’ NDA for Niemann-Pick disease

Beren Therapeutics has received the US Food and Drug Administration (FDA) acceptance to review its New Drug Application (NDA) for adrabetadex, an investigational therapy targeting intracellular cholesterol trafficking for infantile-onset Niemann-Pick disease type C (NPC).

FDA accepts Beren Therapeutics’ NDA for Niemann-Pick disease