Zydus Life's US arm gets FDA nod for paediatric drug CUTX-101 NDA resubmission

Drug firm Zydus Lifesciences Ltd on Monday (December 15) said its wholly-owned US-based subsidiary, Sentynl Therapeutics Inc, announced that the US Food and Drug Administration (FDA) has accepted the resubmission

of its New Drug Application (NDA) for copper histidinate (CUTX-101), a therapy for treating Menkes disease in paediatric patients.

The resubmission has been classified as a Class I response, and the FDA has set January 14, 2026, as the new Prescription Drug User Fee Act (PDUFA) date. Sentynl had submitted the revised NDA on November 14, 2025, following a complete response letter (CRL) received from the FDA on September 30, 2025.

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The complete response letter raised observations regarding the manufacturing site’s cGMP compliance. No other approvability concerns were cited, and the FDA did not identify any deficiencies in the efficacy or safety data for CUTX-101. Clinical data demonstrate improvement in overall survival for Menkes disease patients receiving 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 paediatric genetic disease that impacts an estimated one in 34,810 to as high as one in 8,664 live male births.

"We appreciate the agency's partnership and commitment to expeditiously reviewing our NDA resubmission. The acceptance of the application brings us one step closer to a milestone for patients and families who are living with Menkes disease," Matt Heck, CEO, Sentynl.

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Shares of Zydus Lifesciences Ltd ended at ₹923, down by ₹6.15, or 0.66%, on the BSE today, December 15.