---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-289582"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-12-06T23:59:59+00:00"
generated_at: "2026-06-07T17:18:55.787551+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Phathom's NDA for VOQUEZNA in Non-Erosive GERD accepted by FDA; PDUFA date July 19, 2024

## Summary
- FDA accepted NDA for VOQUEZNA (vonoprazan) for daily heartburn treatment in Non-Erosive GERD.
- Standard 10-month review assigned; PDUFA target action date is July 19, 2024.
- Plans to initiate an additional Phase 3 study in 2024 evaluating VOQUEZNA for As Needed episodic heartburn relief.
- No PPIs are currently approved for as-needed use in Non-Erosive GERD, a potential differentiation.

## SEC filing metadata
- accession: 0001193125-23-289582
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-12-06T23:59:59+00:00
- event_type: regulatory
- 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/1783183/000119312523289582/0001193125-23-289582-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523289582/d595368d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-289582
- JSON: https://secwatch.observer/filing/0001193125-23-289582.json
- Plain text: https://secwatch.observer/filing/0001193125-23-289582.txt

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