Zydus Life's US arm gets FDA nod for Menkes disease drug resubmission

The drug, CUTX-101, is intended for the treatment of Menkes disease, a rare X-linked recessive genetic disorder affecting male children

Zydus Lifesciences on Monday said that the United States Food and Drug Administration (US FDA) has accepted the resubmission of the new drug application (NDA) for copper histidinate (CUTX-101), a therapy for paediatric patients with Menkes disease.

 

The application was filed by Sentynl Therapeutics, a US-based biopharmaceutical company wholly owned by Zydus Lifesciences. The FDA has classified the resubmission as a Class I response and set January 14, 2026 as the new Prescription Drug User Fee Act (PDUFA) target date.

 

Sentynl had resubmitted the NDA on November 14, 2025, after receiving a complete response letter from the regulator on September 30, 2025. The FDA had raised observations related to current good manufacturing practice (cGMP) compliance at the manufacturing site. The agency did not flag concerns related to the drug’s safety or efficacy data, Sentynl said.

 

 

"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," said Matt Heck, chief executive officer (CEO), Sentynl.

 

CUTX-101 is intended for the treatment of Menkes disease, a rare X-linked recessive genetic disorder affecting male children. If approved, it would be the first FDA-approved therapy for the condition, the company added.

 

Zydus Q2 performance

Ahmedabad-based Zydus Lifesciences reported a 17 per cent year-on-year (Y-o-Y) increase in revenue from operations to ₹6,123 crore, while net profit climbed 38 per cent to ₹1,258.6 crore, supported by steady performance in its US and India formulations businesses.

 

The company's US formulations business reported revenues of ₹2,743.7 crore, up 14 per cent Y-o-Y and down 14 per cent sequentially, accounting for 45 per cent of consolidated revenues.

 

Shares of Zydus Lifesciences closed at ₹921.25 apiece, down 0.8 per cent, on the BSE on Monday.