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Stock impact report

Iterum Therapeutics Provides Business Update [Yahoo! Finance]

Iterum Therapeutics plc - Ordinary Share (ITRM) 
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm Check Earnings Report
Company Research Source: Yahoo! Finance
DUBLIN, Ireland and CHICAGO, March 06, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today provided a general business update. Iterum announced that it now expects to resubmit its new drug application (NDA) for oral sulopenem to the U.S. Food and Drug Administration (FDA) in the first half of the second quarter of 2024, earlier than originally planned. Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter (CRL) Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the first half of the fourth quarter of 2024). Based on Iterum's current operating plan, Iterum believes that its existing cash an Show less Read more
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