Archive · 16 Dec 2025
FDA Accepts Resubmission for Zydus's Menkes Disease Drug
Zydus Lifesciences, an Indian drug company, has good news.
Their American team, Sentynl Therapeutics, got a positive response from the US FDA.
The FDA accepted their request to review a medicine called CUTX-101.
This medicine is for a rare disease called Menkes disease, which affects young boys.
The FDA will make a decision by January 14, 2026.
If approved, it will be the first medicine for this disease.
The company is happy because this brings them closer to helping families with this condition.
The stock price of Zydus Lifesciences went down a little on the day this news came out.
FDA accepted the resubmission of the NDA for CUTX-101, a treatment for Menkes disease.
The PDUFA date for a decision is January 14, 2026.
No concerns were raised about the drug's safety or effectiveness, only manufacturing site compliance.
If approved, CUTX-101 will be the first FDA-approved treatment for Menkes disease.
Zydus Lifesciences' stock price ended at ₹923, down 0.66%, on December 15.
- Who
- Zydus Lifesciences Ltd and its subsidiary Sentynl Therapeutics Inc
- What
- FDA accepted the resubmission of the NDA for CUTX-101, a drug for Menkes disease
- When
- December 15, 2025 (NDA resubmitted on November 14, 2025)
- Where
- United States
- Why
- To potentially provide the first FDA-approved treatment for Menkes disease
- Company
- Zydus Lifesciences Ltd
- Subsidiary
- Sentynl Therapeutics Inc
- Drug
- CUTX-101 (copper histidinate)
- Condition
- Menkes disease
- FDA Action
- Accepted NDA resubmission
- PDUFA Date
- January 14, 2026
- Prevalence
- 1 in 34,810 to 1 in 8,664 live male births
- Stock Price Change
- ₹923, down 0.66%
