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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