secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-12-06T23:59:59+00:00
Accession:  0001193125-23-289582
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Phathom's NDA for VOQUEZNA in Non-Erosive GERD accepted by FDA; PDUFA date July 19, 2024
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- FDA accepted NDA for VOQUEZNA (vonoprazan) for daily heartburn treatment in Non-Erosive GERD.
- Standard 10-month review assigned; PDUFA target action date is July 19, 2024.
- Plans to initiate an additional Phase 3 study in 2024 evaluating VOQUEZNA for As Needed episodic heartburn relief.
- No PPIs are currently approved for as-needed use in Non-Erosive GERD, a potential differentiation.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523289582/0001193125-23-289582-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523289582/d595368d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-289582

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