secwatch.observer — SEC 8-K summary
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Issuer:     Iterum Therapeutics plc (ITRMF)
CIK:        0001659323
Form:       8-K
Filed at:   2024-06-21T23:59:59+00:00
Accession:  0000950170-24-075885
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 5.07, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Iterum Therapeutics gets FDA Advisory Committee meeting on Sept 9, 2024 for oral sulopenem NDA for uUTI
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- FDA Advisory Committee to discuss NDA for oral sulopenem (first oral penem in U.S.) for uUTI in adult women; proposed date September 9, 2024.
- Discussion topics: antimicrobial stewardship issues and appropriate target patient population.
- PDUFA action date set at October 25, 2024 for Class II resubmission.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659323/000095017024075885/0000950170-24-075885-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659323/000095017024075885/itrm-20240619.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-075885

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