secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-08-21T23:59:59+00:00
Accession:  0001193125-23-216611
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Phathom submits 6-month stability data for vonoprazan NDA; NVP impurity controlled below limit
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- Submitted 6-month stability data for reformulated vonoprazan tablets to FDA for Erosive GERD NDA.
- NVP (nitrosamine impurity) kept >10-fold below acceptable daily intake limit of 96 ng/day (2.4 ppm) through 6 months.
- PDUFA goal date for NDA resubmission (Class 2) is November 17, 2023.
- If approved, combined US launch for Erosive GERD and H. pylori planned for Q4 2023.
- Data addresses CRL issued Feb 2023 regarding specifications/controls for NVP impurity.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523216611/0001193125-23-216611-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523216611/d486896d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-216611

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