Beren Therapeutics Announces FDA Extension of Review Period for New Drug Application (NDA) for Adrabetadex for the Treatment of Infantile-Onset Niemann-Pick Disease, Type C

▤ Summary

Beren Therapeutics says the FDA has extended its review of the NDA for adrabetadex by three months. The new PDUFA target action date is November 17, 2026. The extension follows the company’s response to an FDA information request, which the agency treated as a Major Amendment. Beren continues to support access to adrabetadex through its Expanded Access Program while it waits for the FDA decision.

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