Zydus Lifescience Arm Gets FDA Acceptance of NDA for Cutx-101

Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is an Indian multinational pharmaceutical company based in Ahmedabad that primarily manufactures generic drugs. The company ranked 100th in the Fortune India 500 list in 2020.

About NDA from the US FDA

Shares of Zydus Lifesciences witnessed an uptick on January 7, 2025, following a significant milestone achieved by its subsidiary, Sentynl Therapeutics. The company announced that the US Food and Drug Administration (USFDA) has granted Priority Review status to its New Drug Application (NDA) for Copper Histidinate injection, marketed as CUTX-101.

The drug is being developed to combat Menkes disease, a rare yet life-threatening genetic disorder caused by copper transport deficiency. This disorder disrupts copper absorption and distribution, leading to severe developmental delays, neurological challenges, and, in some cases, early fatality.

Prescription Drug User Fee Act (PDUFA) 

The Priority Review designation is a testament to the critical role CUTX-101 could play in addressing this unmet medical need. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for July 17, 2025, indicating a faster evaluation timeline for the drug.

Milestone for Zydus Lifesciences 

Zydus Lifesciences is optimistic that this regulatory milestone will pave the way for its subsidiary, Sentynl Therapeutics, to revolutionise the treatment landscape for Menkes disease.

This development underscores Zydus Lifesciences’ relentless commitment to innovation and its mission to address rare diseases with groundbreaking therapeutics.

Share Price Performance 

Zydus Lifesciences Ltd. shares were trading at ₹1,007.00 per share on NSE at 11:09 AM, up over 5%.

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