secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2024-12-11T23:59:59+00:00
Accession:  0001193125-24-274876
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Phathom files Citizen Petition to correct VOQUEZNA Orange Book exclusivity to May 2032
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- Petition requests FDA correct VOQUEZNA tablet listings to reflect 10-year NCE exclusivity ending May 3, 2032.
- Exclusivity stems from GAIN Act extension on vonoprazan, already applied to VOQUEZNA DUAL/TRIPLE PAK approved May 2022.
- FDA must respond within 180 days; may approve, deny, or provide tentative response.
- Corrected listing would block ANDA or 505(b)(2) submissions referencing vonoprazan until expiry.
- Phathom expects CP docket to appear on regulations.gov in coming days.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312524274876/0001193125-24-274876-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312524274876/d904037d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-274876

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