secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-06-12T23:59:59+00:00
Accession:  0001193125-23-164930
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Phathom's vonoprazan NDA resubmission for Erosive GERD; PDUFA date Nov 17, 2023
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- FDA acknowledged NDA resubmission for vonoprazan, a PCAB, as complete response to the February 2023 CRL.
- Classified as a Class 2 resubmission with a PDUFA goal date of November 17, 2023.
- Resubmission included three months stability data of reformulated tablets to support commercial shelf life.
- Additional stability data will be provided during review as previously agreed with the FDA.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523164930/0001193125-23-164930-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523164930/d486645d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-164930

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