The orphan exclusivity removes near-term generic competition risk for ONAPGO, a key growth asset. Monitor the sNDA approval timeline (mid-2027) and upcoming quarterly revenue contributions from ONAPGO to assess commercial traction.
Price Chart
Executive Summary
Supernus announced the FDA recognized seven years of orphan-drug exclusivity for ONAPGO (apomorphine HCl) for advanced Parkinson's disease, effective retroactively from its February 3, 2025 approval date. The company also submitted an sNDA for a second supplier, with potential FDA approval expected by mid-2027. This secures market protection for ONAPGO through February 2032 and addresses prior supply-chain concerns.
Key Facts
- FDA recognized seven years of orphan-drug exclusivity for ONAPGO, effective February 3, 2025 (approval date).
- ONAPGO is the first and only subcutaneous apomorphine infusion device for motor fluctuations in advanced Parkinson's disease.
- Company submitted an sNDA for a second supplier for ONAPGO; expects potential FDA approval by mid-2027.
- Orphan-drug exclusivity provides market protection until February 2032.
- CEO stated the sNDA submission reinforces commitment to uninterrupted drug supply after earlier supply issue.
Financial Impact
No financial figures provided. Orphan-drug exclusivity protects ONAPGO revenue stream through 2032; second supplier approval would mitigate supply disruption risk.
Risk Factors
- Second supplier approval may be delayed beyond mid-2027 or denied by FDA.
- ONAPGO revenue ramp may underperform expectations; no financial data provided in this filing.
- Earlier supply issue referenced by CEO could recur if second supplier approval is delayed.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-117937 |
| Document: tm2628092d1_ex99-1.htm | 0001104659-26-117937 |
| Document: 0001104659-26-117937-index-headers.html | 0001104659-26-117937 |
| Document: 0001104659-26-117937-index.html | 0001104659-26-117937 |
| Document: 0001104659-26-117937.txt | 0001104659-26-117937 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 8-K | $40.77 | awaiting T+5 | — | $40.77 (+0.00%) |
Oct 21, 2026 5d ago | 8-K | $42.07 | awaiting T+5 | — | $40.77 (−3.09%) |
Oct 19, 2026 7d ago | 8-K | $41.23 | awaiting T+5 | — | $40.77 (−1.12%) |
Oct 19, 2026 8d ago | Press Release | $39.84 $40.63 | ▲ +1.98% | ▲ +2.13% | $40.77 (+2.33%) |
Oct 6, 2026 21d ago | 425 | $42.83 $42.01 | ▼ −1.91% | ▼ −1.78% | $40.77 (−4.81%) |
Oct 6, 2026 21d ago | DEFA14A | $42.83 $42.01 | ▼ −1.91% | ▼ −1.78% | $40.77 (−4.81%) |
Sep 11, 2026 6w ago | DEFM14A | $41.49 $42.78 | ▲ +3.11% | ▲ +3.00% | $40.77 (−1.74%) |
Aug 3, 2026 12w ago | DEFA14A / 425 | $43.25 $46.88 | ▲ +8.39% | ▲ +8.49% | $40.77 (−5.73%) |
Aug 3, 2026 12w ago | 8-K | $43.25 $46.88 | ▲ +8.39% | ▲ +8.49% | $40.77 (−5.73%) |
Aug 3, 2026 12w ago | DEFA14A / 425 | $46.00 $47.07 | ▲ +2.33% | ▲ +0.30% | $40.77 (−11.37%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers