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Iterum Therapeutics plc Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections

Iterum Therapeutics plc Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections
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Iterum Therapeutics Plc (ITRM) Resubmits NDA for Oral Sulopenem

Iterum Therapeutics Plc (ITRM) Resubmits NDA for Oral Sulopenem
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Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Resubmission of NDA On Track for Early Q2 24— Cash Runway into 2025, including through Potential FDA Approval in Early Q4 24 Company to host conference call today at 8:30amET DUBLIN, Ireland and CHICAGO, March 28, 2024 (GLOBE NEWSWIRE) Iterum Therapeutics plc (Nasdaq: ITRM), 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 r

United statesJudy matthewsCorey fishmanDrug administrationRecourse royaltyCash runwayChief executiveSpecial protocol assessmentResistant enterobacteralesComplete response letterFinancial advisorFull yearPrescription drug user fee actExchangeable senior subordinated notesIterum therapeuticsQualified infectious disease product

2024-03-28 | NDAQ:ITRM | Press Release | Iterum Therapeutics plc

(2024-03-28 | NDAQ:ITRM) Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

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Why Iterum Therapeutics Stock Is Trending Today - Iterum Therapeutics (NASDAQ:ITRM)

Iterum Therapeutics announced positive topline results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin.

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