secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-02-09T23:59:59+00:00
Accession:  0001193125-23-030011
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Phathom receives FDA complete response letters for vonoprazan NDAs due to nitrosamine impurity
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- CRL for erosive esophagitis NDA and H. pylori post-approval supplement, citing impurity N-nitroso-vonoprazan (NVP).
- FDA requests additional stability data showing NVP remains below acceptable intake throughout shelf life; no other deficiencies.
- Phathom implemented mitigation measures and expects to meet with FDA in Q1 2023 to discuss resubmission timeline.
- This follows January 2023 announcement; delays potential approval and commercial launch of vonoprazan products.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523030011/0001193125-23-030011-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523030011/d426711d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-030011

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