Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
Iterum Therapeutics plc - Ordinary Share (ITRM)
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm
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Source: GlobeNewswire
--SPA supports protocol for Phase 3 Clinical Trial of Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections-- --Clinical Trial Expected to Begin Enrollment in Q4 2022-- DUBLIN, Ireland and CHICAGO, July 11, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, announced today that it has reached an agreement with the U.S. Food and Drug Administration (“FDA”) under the special protocol assessment (“SPA”) process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated urinary tract infections (“uUTI”). The SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to th
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- Iterum Therapeutics plc (NASDAQ: ITRM) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $6.00 price target on the stock.MarketBeat
- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial ResultsGlobeNewswire
- Iterum Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on March 28, 2024GlobeNewswire
- Iterum Therapeutics to Participate in H.C. Wainwright Virtual @Home Fireside Chat [Yahoo! Finance]Yahoo! Finance
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- 3/28/24 - Form 10-K
- ITRM's page on the SEC website