---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-090354"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-04-04T23:59:59+00:00"
generated_at: "2026-06-17T06:33:28.938908+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Phathom provides regulatory update on path to resubmit EE NDA in Q2 2023; launch expected Q4 2023

## Summary
- Met with FDA; CRLs solely related to nitrosamine impurity NVP; mitigation includes minor tablet reformulation.
- Stability data shared with FDA; anticipates resubmitting EE NDA in Q2 2023, with combined EE/H. pylori launch in Q4 2023.
- Also plans to submit PAS for H. pylori; FDA action expected in Q4 2023.

## SEC filing metadata
- accession: 0001193125-23-090354
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-04-04T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312523090354/0001193125-23-090354-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523090354/d495312d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-090354
- JSON: https://secwatch.observer/filing/0001193125-23-090354.json
- Plain text: https://secwatch.observer/filing/0001193125-23-090354.txt

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