---
schema_version: "secwatch.filing_event.v1"
accession: "0001356576-24-000041"
form_type: "8-K"
ticker: "SUPN"
cik: "0001356576"
company_name: "SUPERNUS PHARMACEUTICALS, INC."
filed_at: "2024-08-01T23:59:59+00:00"
generated_at: "2026-05-31T13:42:57.722412+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Supernus resubmits NDA for SPN-830 apomorphine infusion for Parkinson's OFF episodes

## Summary
- Resubmitted NDA for SPN-830 (apomorphine infusion device) to FDA for continuous treatment of OFF episodes in Parkinson's disease.
- CRL in April 2024 identified two areas needing additional info; no clinical safety or efficacy issues were raised.
- Company believes it has fully addressed the FDA's questions from the CRL.
- If approved, SPN-830 could be an important novel therapy for Parkinson's patients.
- Supernus will continue to work closely with the FDA during the NDA review process.

## SEC filing metadata
- accession: 0001356576-24-000041
- form_type: 8-K
- ticker: SUPN
- cik: 0001356576
- company_name: SUPERNUS PHARMACEUTICALS, INC.
- filed_at: 2024-08-01T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1356576/000135657624000041/0001356576-24-000041-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1356576/000135657624000041/supn-20240801.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001356576-24-000041
- JSON: https://secwatch.observer/filing/0001356576-24-000041.json
- Plain text: https://secwatch.observer/filing/0001356576-24-000041.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.