Zydus Lifesciences’ arm receives USFDA’s acceptance for CUTX-101 NDA resubmission

16 Dec 2025 Evaluate

Zydus Lifesciences’ wholly-owned subsidiary -- Sentynl Therapeutics, Inc. (Sentynl), has received acceptance for the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients from U.S. Food and Drug Administration (FDA). The resubmission has been accepted as a Class I response and as a result, the company has received January 14, 2026 as the new PDUFA date.

Sentynl resubmitted its revised NDA on November 14, 2025 after receiving a complete response letter (CRL) from the FDA on September 30, 2025, which cited observations regarding the manufacturing site’s cGMP compliance. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101’s efficacy and safety data, which demonstrate improvement in overall survival for Menkes disease subjects who received early treatment with the therapy.

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease, a rare X-linked recessive pediatric genetic disease that impacts an estimated 1 in 34,810 to as high as 1 in 8,664 live male births. (Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database (gnomAD)).

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.

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