secwatch.observer — SEC 8-K summary
======================================

Issuer:     Vanda Pharmaceuticals Inc. (VNDA)
CIK:        0001347178
Form:       8-K
Filed at:   2025-03-17T23:59:59+00:00
Accession:  0001193125-25-055287
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

Vanda announces FDA accepted tradipitant NDA for motion sickness; PDUFA Dec 30, 2025; firm criticizes timeline
--------------------------------------------------------------------------------

- FDA accepted for filing Vanda's NDA for tradipitant to treat motion sickness; PDUFA target date set for December 30, 2025.
- Vanda says FDA intends to take 12 months for review, 6 months beyond the statutory deadline, calling it a violation of the FD&C Act.
- Clinical data from pooled studies (681 subjects): vomiting in 14.6% (170 mg) and 18.9% (85 mg) vs 41.2% placebo, p<0.0001.
- Vanda publicly criticized the FDA as 'broken and unaccountable' for allegedly stifling innovation and delaying approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1347178/000119312525055287/0001193125-25-055287-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1347178/000119312525055287/d938957d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-055287

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