Zycubo (copper histidinate) PDUFA Date (Sentynl Therapeutics)
FDA PDUFA decision date for Zycubo (copper histidinate) is January 12, 2026. Developed by Sentynl Therapeutics. Indication: Menkes disease. Current status: Approved.
Indication
Menkes disease
Regulatory details
- Company: Sentynl Therapeutics
- Therapeutic area: Rare Disease / Metabolic
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-01-12
- Outcome: Approved