October 26, 2025

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Zydus's Sentynl Therapeutics pediatric Menkes disease drug flagged by USFDA

Solana Beach:Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical companywholly-ownedby Zydus Lifesciences, Ltd., has announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) relating to its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients.

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