Sentynl Therapeutics’ Copper Histidinate (CUTX-101) NDA Analyzed
Sentynl Therapeutics, Inc. has announced a significant step forward in its effort to get CUTX-101 approved for treating Menkes disease in children. The U.S. Food and Drug Administration (FDA) has accepted the company’s updated application. This means they’re closer to a medicine being available to kids with this rare illness.
Key Points
- FDA accepted Sentynl’s revised NDA for CUTX-101.
- New PDUFA date set for January 14, 2026.
- CUTX-101 treats Menkes disease in pediatric patients.
- Resubmission addressed manufacturing site cGMP compliance.
- Efficacy and safety data showed improved survival rates.
- Significant progress towards a new treatment option.
The company, which is part of the Zydus Group, submitted a revised application (NDA) to the FDA. This application is for a drug called CUTX-101. CUTX-101 is designed to treat Menkes disease, a rare genetic disorder that affects how the body uses copper.
Previously, the FDA sent Sentynl a letter saying they needed to improve how the drug is made. However, the FDA now believes they’ve made the necessary changes and has given the application the green light. They have set a new target date of January 14, 2026, for the FDA to make a final decision.
The important thing is that the FDA still thinks CUTX-101 is likely to work. The data from tests showed that the drug helped some kids with Menkes disease live longer. This provides hope for families dealing with this challenging condition.
“This acceptance represents a critical milestone in our journey to deliver a life-changing therapy to patients and families affected by Menkes disease.” – Matt Heck, CEO, Sentynl Therapeutics
