secwatch.observer — SEC 8-K summary
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Issuer:     Vanda Pharmaceuticals Inc. (VNDA)
CIK:        0001347178
Form:       8-K
Filed at:   2025-12-04T23:59:59+00:00
Accession:  0001628280-25-055393
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA lifts partial clinical hold on Vanda's tradipitant for motion sickness
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- FDA lifted partial clinical hold on protocol VP-VLY-686-3403, removing the 90-dose cap on tradipitant studies.
- Lift followed Vanda's formal dispute resolution and expedited re-review under October 2025 collaborative framework.
- FDA agreed motion sickness is acute, event-driven; no additional dog toxicity study required.
- NDA for tradipitant to prevent vomiting due to motion remains under review; PDUFA date December 30, 2025.
- CEO Mihael Polymeropoulos thanked FDA for swift scientific review and constructive dialogue.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1347178/000162828025055393/0001628280-25-055393-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1347178/000162828025055393/vnda-20251204.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-055393

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