regulatory
confidence high
sentiment positive
materiality 0.65
Supernus announces FDA accepted resubmission of SPN-830 NDA; PDUFA date Feb 1, 2025
SUPERNUS PHARMACEUTICALS, INC.
- FDA acknowledged resubmission of NDA for SPN-830 (apomorphine infusion device) for continuous treatment of motor fluctuations in Parkinson's disease.
- Resubmission is considered filed; user fee goal date (PDUFA) set for February 1, 2025.
- SPN-830 targets OFF episodes in Parkinson's disease; Supernus focuses on CNS therapies.