secwatch.observer — SEC 8-K summary
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Issuer:     SUPERNUS PHARMACEUTICALS, INC. (SUPN)
CIK:        0001356576
Form:       8-K
Filed at:   2024-08-19T23:59:59+00:00
Accession:  0001356576-24-000053
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Supernus announces FDA accepted resubmission of SPN-830 NDA; PDUFA date Feb 1, 2025
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1356576/000135657624000053/0001356576-24-000053-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1356576/000135657624000053/supn-20240819.htm
  HTML page:      https://secwatch.observer/filing/0001356576-24-000053

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