---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-151785"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-05-23T23:59:59+00:00"
generated_at: "2026-06-14T17:27:48.346519+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Phathom resubmits NDA for vonoprazan for erosive GERD with stability data controlling nitrosamine impurity

## Summary
- Resubmitted vonoprazan NDA for erosive GERD to FDA after February 2023 Complete Response Letter.
- Stability data from six reformulated batches show NVP levels >10-fold below 96 ng/day intake limit through 3 months.
- NDA classified as Class 2 resubmission with 6-month review; 6-month stability data to be provided during review.
- If approved, combined U.S. commercial launch for erosive GERD and H. pylori indications planned for Q4 2023.
- Phase 3 PHALCON-EE trial enrolled 1,024 patients; compared vonoprazan to lansoprazole.

## SEC filing metadata
- accession: 0001193125-23-151785
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-05-23T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312523151785/0001193125-23-151785-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523151785/d503681d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-151785
- JSON: https://secwatch.observer/filing/0001193125-23-151785.json
- Plain text: https://secwatch.observer/filing/0001193125-23-151785.txt

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