secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2025-06-16T23:59:59+00:00
Accession:  0001193125-25-141119
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA Orange Book corrected; VOQUEZNA NCE exclusivity confirmed through May 2032
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- FDA updated Orange Book to show full 10-year NCE exclusivity for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets.
- Corrected listing confirms exclusivity runs through May 3, 2032, aligning with statutory requirements.
- Phathom says this reinforces the long-term commercial runway for its first-in-class product.
- NCE exclusivity prevents generic competition for the full 10-year period from approval date.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312525141119/0001193125-25-141119-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312525141119/d924090d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-141119

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