Iterum's oral sulopenem acceptance hinges on antibiotic stewardship efforts [Yahoo! Finance]
Iterum Therapeutics plc - Ordinary Share (ITRM)
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm
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Source: Yahoo! Finance
meeting raised concerns about the potential risks of providing an oral antibiotic for uncomplicated urinary tract infections (uUTIs). On September 9, the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) examined Iterum Therapeutics's antibiotic oral sulopenem. Iterum's drug, which is sulopenem etzadroxil combined with probenecid in a bilayer tablet, is a thiopenem antibiotic. If approved, it could become the first oral penem available in the US to treat uUTIs. This was not the first time Iterum's sulopenem reached the regulator. In July 2021, the FDA issued a complete response letter rejecting Iterum's antibiotic due to insufficient evidence of effectiveness in the Phase III uUTI 301 (NCT03354598) and 310 (NCT05584657) trials. In the former study, oral sulopenem demonstrated efficacy in the ciprofloxacin-resistant patient cohort, but it was not effective in the ciprofloxacin-susceptible population, primarily due to microbiologic failure. Similarly, in the 310 study, Iterum's s
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News
- Iterum Therapeutics to Host Morning Conference Call on U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract InfectionsPR Newswire
- Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract InfectionsGlobeNewswire
- Iterum Therapeutics to Present Data at IDWeek 2024GlobeNewswire
- Iterum Therapeutics to Participate at the 2024 Maxim Healthcare Virtual SummitGlobeNewswire
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Earnings
- 8/14/24 - Beat
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- 9/10/24 - HC Wainwright
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Sec Filings
- 10/30/24 - Form 424B5
- 10/28/24 - Form 424B5
- 10/25/24 - Form 8-K
- ITRM's page on the SEC website