Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
Iterum Therapeutics plc - Ordinary Share (ITRM)
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm
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Source: GlobeNewswire
--First Oral Penem in the U.S. and Second New Oral Treatment for uUTIs in Over 25 Years, if approved-- --Potential Approval Early Q4 2024-- DUBLIN, Ireland and CHICAGO, April 29, 2024 (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, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. “The resubmission of the NDA filing for oral sulopenem is a significant step forward in bringing a new antibiotic to the market for women that suffer from an estimated 40 million uUTIs each year in the U.S.,” said Corey Fishman, Chief Executive Officer. “The availability of or
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News
- 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 First Quarter 2024 Financial ResultsGlobeNewswire
- Iterum Therapeutics to Report First Quarter 2024 Financial Results on May 13, 2024 [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics to Report First Quarter 2024 Financial Results on May 13, 2024GlobeNewswire
- 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
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- 5/13/24 - Beat
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Sec Filings
- 5/13/24 - Form 10-Q
- 5/13/24 - Form 8-K
- 5/10/24 - Form 8-K
- ITRM's page on the SEC website