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260,280 Results for "iterum therapeutics".
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Approvals
Iterum Wins FDA Approval For Oral UTI Antibiotic, Seeks ‘Strategic Transaction’ for Asset
Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders.
October 28, 2024
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2 min read
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Tristan Manalac
Press Releases
Iterum Therapeutics to Host Morning Conference Call on U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections
October 28, 2024
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2 min read
Regulatory
FDA Action Alert: Amgen, Camurus, Iterum and Lexicon
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
October 14, 2024
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4 min read
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Tristan Manalac
Drug Development
Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
Iterum Therapeutics today 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® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTIs).
January 30, 2024
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9 min read
BioMidwest
Iterum Therapeutics to Present Data at IDWeek 2022
Iterum Therapeutics plc announced that two posters will be presented at the Infectious Disease Society of America’s IDWeek 2022.
October 17, 2022
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2 min read
Business
Iterum Therapeutics Reports Third Quarter 2022 Financial Results
Iterum Therapeutics plc, 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, reported financial results for the third quarter ended September 30, 2022.
November 10, 2022
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14 min read
Business
Iterum Therapeutics to Provide Business Update and Report Third Quarter 2022 Financial Results on November 10, 2022
Iterum Therapeutics plc announced that the Company will release its third quarter 2022 financial results before the open of the U.S. financial markets on Thursday, November 10, 2022.
November 3, 2022
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1 min read
BioMidwest
Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
Iterum Therapeutics plc today announced the United States Patent and Trademark Office has issued the Company a Notice of Allowance for U.S. patent application number 16/972,300.
September 19, 2022
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5 min read
Business
Iterum Therapeutics Reports First Quarter 2022 Financial Results
Iterum Therapeutics plc (Nasdaq: ITRM) (“Iterum”), 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 reported financial results for the first quarter ended March 31, 2022.
May 13, 2022
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12 min read
Policy
Iterum Therapeutics Regains Compliance with Nasdaq Bid Price Rule - Sep 01, 2022
Iterum Therapeutics plc announced that it has received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550 for continued listing on The Nasdaq Capital Market.
September 1, 2022
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2 min read
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