Zydus Life's Sentynl: FDA accepts CUTX-101 NDA resubmission for Menkes disease drug

• Zydus Lifesciences' US subsidiary, Sentynl Therapeutics Inc, announced the FDA has accepted the resubmission of its New Drug Application (NDA) for CUTX-101.
• CUTX-101 is a therapy for treating Menkes disease in paediatric patients.
• The FDA has set January 14, 2026, as the new Prescription Drug User Fee Act (PDUFA) date for the resubmission.
• The previous complete response letter (CRL) was due to manufacturing site cGMP compliance, with no concerns about the drug's efficacy or safety.
• If approved, CUTX-101 would be the first and only FDA-approved treatment available for the rare paediatric genetic Menkes disease.

Why It Matters: First FDA-approved treatment for rare pediatric Menkes disease is closer.