---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-164930"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-06-12T23:59:59+00:00"
generated_at: "2026-06-14T03:07:09.419818+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Phathom's vonoprazan NDA resubmission for Erosive GERD; PDUFA date Nov 17, 2023

## Summary
- FDA acknowledged NDA resubmission for vonoprazan, a PCAB, as complete response to the February 2023 CRL.
- Classified as a Class 2 resubmission with a PDUFA goal date of November 17, 2023.
- Resubmission included three months stability data of reformulated tablets to support commercial shelf life.
- Additional stability data will be provided during review as previously agreed with the FDA.

## SEC filing metadata
- accession: 0001193125-23-164930
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-06-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312523164930/0001193125-23-164930-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523164930/d486645d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-164930
- JSON: https://secwatch.observer/filing/0001193125-23-164930.json
- Plain text: https://secwatch.observer/filing/0001193125-23-164930.txt

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