Solana Beach: Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical company wholly-owned by 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. The USFDA provided findings within the CRL that Sentynl and Zydus Lifesciences will need to address to clarify the path forward. Specifically, the USFDA mentioned a CGMP inspection of the facility where CUTX101 is manufactured. Zydus recently provided responses to USFDA’s September 2025 re-inspection demonstrating the facility’s CGMP compliance and is awaiting USFDA’s Establishment Inspection Report (EIR). Sentynl will requ

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