secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-01-03T23:59:59+00:00
Accession:  0001193125-23-000749
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA delays action on Phathom's vonoprazan EE NDA; nitrosamine impurity data required, launch pushed past Q1 2023
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- FDA will not act by Jan 11, 2023 PDUFA date for vonoprazan erosive esophagitis NDA.
- Acceptable daily intake for nitrosamine impurity NVP set at 96 ng/day; additional stability data required.
- Phathom no longer expects product launches for H. pylori or EE in Q1 2023.
- Company is generating additional stability data and discussing nature/extent with FDA.
- Previously identified NVP impurity in commercial batches delays both indications.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523000749/0001193125-23-000749-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523000749/d277519d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-000749

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