secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-05-23T23:59:59+00:00
Accession:  0001193125-23-151785
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523151785/0001193125-23-151785-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523151785/d503681d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-151785

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