---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-241941"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-09-26T23:59:59+00:00"
generated_at: "2026-06-10T08:47:38.156951+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Phathom submits NDA to FDA for vonoprazan as daily Non-Erosive GERD treatment

## Summary
- NDA for vonoprazan as daily treatment for Non-Erosive GERD in adults submitted to FDA, supported by Phase 3 PHALCON-NERD-301 study.
- Primary endpoint met: 45% (10 mg) and 44% (20 mg) heartburn-free days vs 28% placebo (p<0.0001).
- 20-week extension study showed 61-63% heartburn-free days for vonoprazan doses.
- FDA review expected 10 months; potential Q3 2024 U.S. launch if approved.
- Vonoprazan under review for Erosive GERD with PDUFA date Nov 17, 2023; Q4 2023 launch planned if approved.

## SEC filing metadata
- accession: 0001193125-23-241941
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-09-26T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312523241941/0001193125-23-241941-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523241941/d535060d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-241941
- JSON: https://secwatch.observer/filing/0001193125-23-241941.json
- Plain text: https://secwatch.observer/filing/0001193125-23-241941.txt

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