---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-000749"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-01-03T23:59:59+00:00"
generated_at: "2026-06-20T20:58:24.546071+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA delays action on Phathom's vonoprazan EE NDA; nitrosamine impurity data required, launch pushed past Q1 2023

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-23-000749
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-01-03T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312523000749/0001193125-23-000749-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523000749/d277519d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-000749
- JSON: https://secwatch.observer/filing/0001193125-23-000749.json
- Plain text: https://secwatch.observer/filing/0001193125-23-000749.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.