secwatch.observer — SEC 8-K summary
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Issuer:     SUPERNUS PHARMACEUTICALS, INC. (SUPN)
CIK:        0001356576
Form:       8-K
Filed at:   2025-02-04T23:59:59+00:00
Accession:  0001356576-25-000004
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Supernus receives FDA approval for ONAPGO as first subcutaneous apomorphine infusion device for Parkinson's
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- ONAPGO approved for continuous treatment of motor fluctuations in advanced Parkinson's patients not controlled by oral levodopa.
- Phase 3 study: ONAPGO reduced daily OFF time by 2.6 hours vs 0.9 hours placebo (p=0.0114); GOOD ON time increased 2.8 vs 1.1 hours.
- Product will be available in the U.S. in Q2 2025, with a support team including nurse education programs.
- Most common adverse events (≥10%): infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, insomnia.
- CEO Jack Khattar stated ONAPGO demonstrates Supernus' continued commitment to CNS innovation.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1356576/000135657625000004/0001356576-25-000004-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1356576/000135657625000004/supn-20250204.htm
  HTML page:      https://secwatch.observer/filing/0001356576-25-000004

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer