secwatch.observer — SEC 8-K summary
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Issuer:     Vanda Pharmaceuticals Inc. (VNDA)
CIK:        0001347178
Form:       8-K
Filed at:   2025-12-31T23:59:59+00:00
Accession:  0001628280-25-059155
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves Vanda's NEREUS (tradipitant) for motion sickness prevention; first new drug in 40+ years
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- FDA approved NEREUS (tradipitant) on Dec 30, 2025 for prevention of vomiting induced by motion; first new drug class for motion sickness in >40 years.
- Pivotal Phase 3 trials: vomiting incidence 18.3-19.5% with NEREUS vs 44.3% placebo (Motion Syros, p<0.0001); 10.4-18.3% vs 37.7% (Motion Serifos, p≤0.0014).
- Vanda plans to launch NEREUS in coming months; also advancing tradipitant for gastroparesis and GLP-1 agonist-induced nausea.
- Mechanism: NK-1 receptor antagonist, targets substance P pathway underlying nausea/vomiting.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1347178/000162828025059155/0001628280-25-059155-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1347178/000162828025059155/vnda-20251230.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-059155

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