Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease
Shots:
- Fortress and its subsidiary, Cyprium, have reported the US FDA’s NDA acceptance & priority review of CUTX-101 (copper histidinate) to treat Menkes disease, with the decision expected on Jun 30, 2025
- Submission was based on a trial of CUTX-101 vs untreated historical control that depicted significantly improved OS & an 80% reduction in the death risk, with mOS of 177.1 vs 16.1mos.
- Cyprium will also get up to $129M as development & sales milestones from Sentynl based on an agreement signed b/w them in Dec 2023. Sentynl was responsible for the regulatory submission & will handle the commercial activities while Cyprium holds on to the PRV ownership, if granted upon approval
Ref: Fortress Biotech | Image: Fortress Biotech & Cyprium Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
