secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-10-30T23:59:59+00:00
Accession:  0001193125-23-265692
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves reformulated vonoprazan for H. pylori; launch expected Dec 2023
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- FDA approved prior approval supplements for reformulated vonoprazan tablets in VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for H. pylori infection in adults.
- Product expected to be available in the U.S. in December 2023 and marketed exclusively by Phathom.
- H. pylori infects an estimated 115 million individuals in the U.S.; 36% of the U.S. population estimated to be infected.
- Phathom planning combined U.S. commercial launch of H. pylori regimens and Erosive GERD vonoprazan, if approved.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523265692/0001193125-23-265692-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523265692/d491934d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-265692

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