secwatch.observer — SEC 8-K summary
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Issuer:     Vanda Pharmaceuticals Inc. (VNDA)
CIK:        0001347178
Form:       8-K
Filed at:   2025-11-28T23:59:59+00:00
Accession:  0001628280-25-054225
Event type: regulatory
Sentiment:  neutral
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends parcial clinical hold re-review to Dec 5; PDUFA date remains Dec 30 for tradipitant
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- FDA and Vanda agreed to extend partial clinical hold re-review target to Dec 5, 2025 (from Nov 26) due to CDER personnel transitions.
- PDUFA action date for tradipitant NDA for motion sickness vomiting prevention unchanged at December 30, 2025.
- FDA issued labeling comments; labeling discussions with Vanda have formally commenced.
- Vanda aims to deliver first new pharmacologic treatment for motion sickness in over 40 years.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1347178/000162828025054225/0001628280-25-054225-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1347178/000162828025054225/vnda-20251128.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-054225

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