secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-09-26T23:59:59+00:00
Accession:  0001193125-23-241941
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523241941/0001193125-23-241941-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523241941/d535060d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-241941

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer