---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-216611"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-08-21T23:59:59+00:00"
generated_at: "2026-06-11T06:24:00.707361+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Phathom submits 6-month stability data for vonoprazan NDA; NVP impurity controlled below limit

## Summary
- Submitted 6-month stability data for reformulated vonoprazan tablets to FDA for Erosive GERD NDA.
- NVP (nitrosamine impurity) kept >10-fold below acceptable daily intake limit of 96 ng/day (2.4 ppm) through 6 months.
- PDUFA goal date for NDA resubmission (Class 2) is November 17, 2023.
- If approved, combined US launch for Erosive GERD and H. pylori planned for Q4 2023.
- Data addresses CRL issued Feb 2023 regarding specifications/controls for NVP impurity.

## SEC filing metadata
- accession: 0001193125-23-216611
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-08-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312523216611/0001193125-23-216611-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523216611/d486896d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-216611
- JSON: https://secwatch.observer/filing/0001193125-23-216611.json
- Plain text: https://secwatch.observer/filing/0001193125-23-216611.txt

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