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FDA Accepts CUTX-101 NDA Resubmission By Zydus US Arm

Infosys Completes Share Buyback, Extinguishes 10 Crore Shares

Synopsis:


The US FDA has accepted the NDA resubmission for CUTX-101, a paediatric therapy for Menkes disease, developed by Zydus Lifesciences’ US arm. The review has been classified as Class I, with a PDUFA target date of 14 January 2026.


Source:
 Zydus Lifesciences Press Release (NSE Exchange Fillings) | Published on Dec 15, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

As quoted in the press release of Zydus Lifesciences (NSE Exchange Filings), the company’s wholly owned US subsidiary, Sentynl Therapeutics, has received acceptance from the US Food and Drug Administration for the resubmission of the New Drug Application for CUTX-101. The investigational drug is intended for the treatment of Menkes disease in paediatric patients. The FDA has classified the filing as a Class I resubmission and assigned a new PDUFA Target Action Date of 14 January 2026.

This regulatory update marks progress for the application after the agency issued a complete response letter in September 2025. The earlier communication focused on observations related to current Good Manufacturing Practice compliance at the manufacturing site and did not raise concerns on clinical data related to safety or efficacy.

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ZYDUS LIFESCIENCES LTD

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918.4-3.19 (-0.34 %)

Updated - 16 December 2025
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Key Takeaways

  • FDA accepts CUTX-101 NDA resubmission as a Class I response

  • New PDUFA Target Action Date set for 14 January 2026

  • Earlier FDA observations were limited to manufacturing compliance

  • No deficiencies cited in safety or efficacy data

  • CUTX-101 targets Menkes disease in paediatric patients

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Details Of The NDA Resubmission

Sentynl Therapeutics resubmitted the NDA on 14 November 2025 after addressing the issues highlighted in the complete response letter dated 30 September 2025. The FDA review had focused on compliance matters at the manufacturing facility. The agency did not identify gaps in the clinical programme supporting CUTX-101.

Clinical data submitted with the application showed improvement in overall survival among Menkes disease patients who received early treatment. The resubmission process followed standard regulatory timelines and documentation requirements applicable to Class I responses.

About CUTX-101 And Menkes Disease

CUTX-101 is a copper histidinate formulation developed to address copper deficiency associated with Menkes disease. Menkes disease is a rare X-linked recessive genetic disorder that affects copper transport in the body and primarily impacts male infants. The condition can lead to severe neurological and developmental issues if not managed early.

The estimated prevalence of Menkes disease ranges from approximately one in 34,810 to one in 8,664 live male births, based on genomic database estimates. At present, there is no FDA-approved therapy specifically indicated for this condition.

Regulatory Significance

If approved, CUTX-101 would become the first FDA-approved treatment for Menkes disease. The acceptance of the NDA resubmission allows the regulatory review process to move forward within a defined timeline. The outcome of the FDA review remains subject to completion of the agency’s standard evaluation procedures.

Developments related to rare disease therapies often draw attention within the pharmaceutical sector due to their regulatory complexity and limited treatment options.

Snapshot Of Key Regulatory Milestones

Particulars

Details

Drug Candidate

CUTX-101 (Copper Histidinate)

Indication

Menkes Disease (Paediatric)

NDA Resubmission Date

14 November 2025

FDA Classification

Class I Resubmission

New PDUFA Date

14 January 2026

Previous FDA Observation

Manufacturing cGMP Compliance

Share Price Update

Zydus Lifesciences share price stands at ₹922 per share on the BSE as of 15 December 2025 at 3:30 PM IST, up by 0.8%.

Published Date : 16 Dec 2025

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