Iterum Therapeutics plc
iterumtx.comWhat Do They Do?
Develops and sells oral and intravenous antibiotics for urinary tract and intra-abdominal infections, serving patients through community and hospital care.
10-K for FY2024, filed Feb 7, 2025We are a pharmaceutical company dedicated to maximizing the commercial potential of ORLYNVAH™, the first oral branded penem available in…View ↗
Who Are Their Customers?
The approved oral antibiotic is for adult women treated for uncomplicated urinary tract infections, and the company launched it into the U.S. community market with a commercialization partner.
10-K for FY2024, filed Feb 7, 2025 8-K, filed Oct 16, 2025On October 25, 2024, we received approval from the U.S. Food and Drug Administration (FDA) of our New Drug Application (NDA) for ORLYNVAH™…View ↗
The Company commercially launched ORLYNVAH™ into the community market in the U.S. in August 2025 and expects modest sales in 2025 during…View ↗
How Are They Changing?
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Mar 31, 2026
Nasdaq will delist the company’s ordinary shares
Trading suspension is scheduled, following the company’s withdrawal of its appeal after filing a winding-up petition.
Sources
8-K, filed Mar 31, 2026
Also as previously disclosed, on March 27, 2026, the Company filed a petition in the High Court in Ireland to wind up the Company (the…View ↗
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Mar 27, 2026
Company filed a petition to wind up and appointed provisional liquidators
The CEO and CFO resigned, and executive authority passed to the joint provisional liquidators.
Sources
8-K, filed Mar 27, 2026
On March 27, 2026, Iterum Therapeutics plc (the “Company”) filed a petition in the High Court in Ireland to wind up the Company (the…View ↗
From development to a commercial launch
The older report describes sulopenem as a clinical-stage program and planned commercialization after approval; the latest report describes ORLYNVAH as FDA-approved and focuses on commercializing the oral product.
10-K for FY2021, filed Mar 28, 2022 10-K for FY2024, filed Feb 7, 2025We are a pharmaceutical company dedicated to maximizing the commercial potential of ORLYNVAH™, the first oral branded penem available in…View ↗
On October 25, 2024, we received approval from the U.S. Food and Drug Administration (FDA) of our New Drug Application (NDA) for ORLYNVAH™…View ↗
After receiving positive data from our Phase 3 clinical trial known as REnewed ASsessment of Sulopenem in uUTI caused by Resistant…View ↗
Who Do They Compete With?
Competes with GlaxoSmithKline, AbbVie, Pfizer, Melinta Therapeutics, Merck, Cipla, Innoviva, and Shionogi
10-K for FY2024, filed Feb 7, 2025There are a variety of available oral therapies marketed for the treatment of multi-drug resistant infections that we expect to compete…View ↗
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