ITRM - Earnings announcements

--Commercially Launched ORLYNVAH™ in the United States in August 2025-- --Extended Cash Runway into Q2 2026-- --Company to host conference call today at 8:30amET-- DUBLIN, Ireland and CHICAGO, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (the Company or Iterum), a company focused on delivering 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 quarter ended September 30, 2025. "We are thrilled to have launched ORLYNVAH™ in the United States in August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs)," said

DUBLIN, Ireland and CHICAGO, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (Company), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company will release its third quarter 2025 financial results before the open of the U.S. financial markets on Friday, November 14, 2025. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 404-975-4839 (international) and refer to Ac

-- Launch of ORLYNVAHTM Expected August 2025— --Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN and CHICAGO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a company focused on delivering 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 second quarter ended June 30, 2025. "We are on track to launch ORLYNVAH™ this month for the treatment of uncomplicated urinary tract infections (uUTIs)," said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. "We're proud to introduce the first br

DUBLIN, Ireland and CHICAGO, July 29, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (Company), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company will release its second quarter 2025 financial results before the open of the U.S. financial markets on Tuesday, August 5, 2025. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 404-975-4839 (international) and refer to Acc

U.S. Commercial Launch of ORLYNVAHTM by Q4 2025; First Oral Penem Available in the U.S. Management to host a conference call at 4:30 p.m. ET today DUBLIN and CHICAGO, June 11, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (the "Company" or "Iterum"), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that it entered into a Product Commercialization Agreement (the "Agreement") with EVERSANA Life Science Services, LLC ("EVERSANA") for the commercialization of the Company's approved product, ORLYNVAHTM.   Pursuant to the Agreement, EVERSA

DUBLIN, Ireland and CHICAGO, May 06, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (Company), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company will release its first quarter 2025 financial results before the open of the U.S. financial markets on Tuesday, May 13, 2025. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 404-975-4839 (international) and refer to Access

--ORLYNVAHTM Approved by FDA in Q4 2024— --Extended Cash Runway-- --Company to host conference call today at 8:30amET-- DUBLIN and CHICAGO, Feb. 07, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a company focused on delivering 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 fourth quarter and year ended December 31, 2024. "While outreach to potential strategic partners is our priority and ongoing, we have begun pre-commercialization work to ensure ORLYNVAHTM is made available to patients as soon as possible to address the substantial u

DUBLIN, Ireland and CHICAGO, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (Company), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company will release its fourth quarter and full year 2024 financial results before the open of the U.S. financial markets on Friday, February 7, 2025. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 404-975-4839 (international) a

-- ORLYNVAHTM Approved by FDA on October 25, 2024— --Company to Host Conference Call Today at 8:30 a.m. EDT-- DUBLIN and CHICAGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), (Iterum), a company focused on delivering 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 third quarter ended September 30, 2024. "With last month's approval of ORLYNVAHTM, we have renewed our outreach to potential strategic partners," said Corey Fishman, Iterum's Chief Executive Officer. "As the only oral penem antibiotic approved for commercial sa

DUBLIN and CHICAGO, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (Company), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company will release its third quarter 2024 financial results before the open of the U.S. financial markets on Thursday, November 14, 2024. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 404-975-4839 (international) and refer to Access

Monday, October 28, 2024, at 8:30 a.m. EDT DUBLIN and CHICAGO, Oct. 28, 2024 /PRNewswire/ -- WHO: Iterum Therapeutics plc (NASDAQ:ITRM) is focused on deliveringdifferentiated anti-infectives aimed at combatting the global crisis of multi-drugresistant pathogens to significantly improve the lives of people affected byserious and life-threatening diseases around the world.   WHAT: Conference call to discuss U.S. Food and Drug Administration (FDA) approval ofIterum's ORLYNVAH™ (Oral Sulopenem) for the treatment of uncomplicatedurinary tract infections (uUTIs).Speakers include: Co

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades --Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT-- DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum's new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alter

-- FDA PDUFA Action Date of October 25, 2024; Advisory Committee Meeting on September 9, 2024— --Cash Runway into 2025, including through PDUFA Action Date-- --Company to Host Conference Call Today at 8:30 a.m. EDT-- DUBLIN and CHICAGO, Aug. 14, 2024 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2024. "We are pleased to have recently closed our rights offering, the proceeds of which all

DUBLIN and CHICAGO, Aug. 07, 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 the Company will release its second quarter 2024 financial results before the open of the U.S. financial markets on Wednesday, August 14, 2024. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 404-975-4839 (i

--NDA Resubmitted; FDA Action Expected in Early Q4 24-- --Cash Runway into 2025, including through Potential FDA Approval-- --Company to Host Conference Call Today at 8:30 a.m. EDT-- DUBLIN, Ireland and CHICAGO, May 13, 2024 (GLOBE NEWSWIRE) -- 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, 2024. "We are pleased to have recently resubmitted our new drug application (NDA) for oral sulopenem just thre

DUBLIN, Ireland and CHICAGO, May 06, 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 the Company will release its first quarter 2024 financial results before the open of the U.S. financial markets on Monday, May 13, 2024. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 404-975-4839 (in

--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 reported financial results for the fourth quarter and year ended December 31, 2023. "Since we announced positive topline data from our REASSURE trial in January, we've made significant progress in

DUBLIN, Ireland and CHICAGO, March 21, 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 the Company will release its fourth quarter and full year 2023 financial results before the open of the U.S. financial markets on Thursday, March 28, 2024. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic

Phase 3 REASSURE Trial Met Primary Endpoint of Non-Inferiority to Augmentin®; Demonstrated Statistical Superiority Re-submission of NDA to FDA Expected in Q2 2024 Potential to be First Oral Penem Approved in the U.S. Management to host a conference call at 8:30 a.m. ET today DUBLIN and CHICAGO, Jan. 30, 2024 /PRNewswire/ -- 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 announced positive topline results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 c

-- Top-line Data for Pivotal REASSURE Trial Expected in Early Q1 2024 – --Resubmission of NDA for uUTI Expected in Q2 2024-- DUBLIN, Ireland and CHICAGO, Nov. 14, 2023 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2023. "Last month, we completed the enrollment of 2,229 patients in our REASSURE trial in a 12-month period and expect to report top-line data early in the first quarter of 2024,"

DUBLIN, Ireland and CHICAGO, Nov. 07, 2023 (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 the Company will release its third quarter 2023 financial results before the open of the U.S. financial markets on Tuesday, November 14, 2023. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or 929-526-1

DUBLIN, Ireland and CHICAGO, Aug. 04, 2023 (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 the Company will release its second quarter 2023 financial results before the open of the U.S. financial markets on Friday, August 11, 2023. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 833-470-1428 (domestic) or Global Dial

DUBLIN, Ireland and CHICAGO, March 09, 2023 (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 the Company will release its fourth quarter and fully year 2022 financial results before the open of the U.S. financial markets on Thursday, March 16, 2023. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 844-200-6205 (domesti

DUBLIN, Ireland and CHICAGO, Nov. 03, 2022 (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 the Company will release its third quarter 2022 financial results before the open of the U.S. financial markets on Thursday, November 10, 2022. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 844-200-6205 (domestic) or 929-526-

DUBLIN, Ireland and CHICAGO, Aug. 16, 2022 (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, announced today that it will effect a 1-for-15 reverse share split of its outstanding ordinary shares at 5.00 p.m. Eastern Time on August 17, 2022, which will be effective for trading purposes on the Nasdaq Capital Market as of the commencement of trading on August 18, 2022. At the Annual General Meeting of Shareholders on June 15, 2022, the Company's shareholders approved

--Registration Trial for uUTI Planned in Second Half of 2022----Cash Runway into 2024-- --Company to host conference call today at 8:30am ET-- DUBLIN, Ireland and CHICAGO, March 28, 2022 (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 reported financial results for the fourth quarter and year ended December 31, 2021. "Based on several recent interactions with the FDA, we believe that we have made progress towards an agreement on the additional Phase 3 trial design requi

DUBLIN, Ireland and CHICAGO, March 21, 2022 (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 the Company will release its fourth quarter and full year 2021 financial results before the open of the U.S. financial markets on Monday, March 28, 2022. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 844-200-6205 (domestic)

--Type B meeting with FDA requested to affirm design for additional Phase 3 trial needed for resubmission of NDA for Oral Sulopenem-- --Cash Runway into 2024--    --Iterum to host conference call today at 8:30am ET-- DUBLIN, Ireland and CHICAGO, Nov. 12, 2021 (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 reported financial results for the third quarter ended September 30, 2021. "We had a productive Type A meeting with the U.S. Food and Drug Administration (FDA) in t

DUBLIN, Ireland and CHICAGO, Nov. 05, 2021 (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 the Company will release its third quarter 2021 financial results before the open of the U.S. financial markets on Friday, November 12, 2021. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To access the call please dial 844-200-6205 (domestic) or 929-526-15

--Type A meeting with FDA expected late Q3 to define pathway to potential approval for Oral Sulopenem following July's Complete Response Letter-- --Cash Runway into Second Half of 2023--  --Company to host conference call today at 8:30am ET-- DUBLIN, Ireland and CHICAGO, Aug. 13, 2021 (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 reported financial results for the second quarter ended June 30, 2021. "Despite our disappointment with the FDA's Complete Response Letter

DUBLIN, Ireland and CHICAGO, Aug. 06, 2021 (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 the Company will release its second quarter 2021 financial results before the open of the U.S. financial markets on Friday, August 13, 2021. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business. To register for the conference call please use this link: https://eve

--First Oral Penem in the U.S. and First New Oral Treatment for uUTIs in Over 20 Years, if approved-- --Potential Approval Q3 2021 with Priority Review-- DUBLIN, Ireland and CHICAGO, Nov. 30, 2020 (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 submitted 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