Iterum Therapeutics plc, a clinical-stage pharmaceutical company, engages in developing anti-infectives for multi-drug resistant pathogens in Ireland and the United States. It is developing sulopenem, a novel anti-infective compound with oral and IV formulations that is in Phase III clinical trials for the treatment of uncomplicated urinary tract infections, complicated urinary tract infections, and complicated intra-abdominal infections. The company was founded in 2015 and is headquartered in Dublin, Ireland.
IPO Year: 2018
Exchange: NASDAQ
Website: iterumtx.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
7/27/2021 | Sell → Hold | Gabelli & Co. | |
7/26/2021 | Buy → Neutral | HC Wainwright & Co. |
-- 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
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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 commenced its previously disclosed rights offering (the "Rights Offering"). Pursuant to the Rights Offering, the Company is distributing, at no charge, subscription rights to the Company's shareholders and holders of warrants that have contractual rights to participate in the Rights Offering which have not been waived (each, an "eligible warrant" and collectively, the "eligible warrants") as of 5:00 p.m., E
HC Wainwright & Co. analyst Ed Arce reiterates Iterum Therapeutics (NASDAQ:ITRM) with a Buy and maintains $6 price target.
HC Wainwright & Co. analyst Ed Arce reiterates Iterum Therapeutics (NASDAQ:ITRM) with a Buy and maintains $6 price target.
HC Wainwright & Co. analyst Ed Arce reiterates Iterum Therapeutics (NASDAQ:ITRM) with a Buy and maintains $6 price target.
HC Wainwright & Co. analyst Ed Arce reiterates Iterum Therapeutics (NASDAQ:ITRM) with a Buy and maintains $6 price target.
FDA Decision Expected by PDUFA Goal Date of October 25, 2024 Potential to be First Oral Penem Approved in the U.S. DUBLIN and CHICAGO, Sept. 10, 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 announced that a meeting of the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) took place on September 9, 2024 at which Iterum's new drug application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary
DUBLIN, Ireland and CHICAGO, Sept. 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 announced that Corey Fishman, Iterum's Chief Executive Officer, will present and host investor meetings at the 26th Annual H.C. Wainwright Global Investment Conference held September 9 to September 11, 2024, at the Lotte New York Palace Hotel. Admission to H.C. Wainwright's conference is for qualified investors. Iterum will be giving a presentation at 8:30 am ET on September 10, 2024. Management w
-- 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
DUBLIN and CHICAGO, Aug. 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 subscription period of its previously announced rights offering (the "Rights Offering") expired at 5:00 p.m., Eastern Time, on August 6, 2024. As previously disclosed, the Company distributed, at no charge, subscription rights to the Company's shareholders and holders of warrants that had contractual rights to participate in the Rights Offering which were no
DUBLIN and CHICAGO, Aug. 02, 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 announced the United States Patent and Trademark Office (USPTO) has issued a notice allowance for two U.S. patents and the Canadian Intellectual Property Office (CIPO) has issued a Canadian patent, all related to sulopenem etzadroxil and probenecid (oral sulopenem). "We are very pleased to continue to strengthen our oral sulopenem patent estate further with the addition of t
DUBLIN and CHICAGO, July 22, 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 it has commenced its previously disclosed rights offering (the "Rights Offering"). Pursuant to the Rights Offering, the Company is distributing, at no charge, subscription rights to the Company's shareholders and holders of warrants that have contractual rights to participate in the Rights Offering which have not been waived (each, an "eligible warrant" and col
DUBLIN, Ireland and CHICAGO, June 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 U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women will be taken to Advisory Committee, and in its communication, highlighted that the purpose of the Advisory Committee was to d
DUBLIN and CHICAGO, June 05, 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 present a poster at the American Society for Microbiology (ASM) Microbe 2024 meeting, being held June 13-17, 2024, in Atlanta, Georgia. Data to be presented includes: Presentation title: In Vitro Assessment of Sulopenem against Mycobacterium avium ComplexPresentation type/category: AAR08 New Antimicrobial Agents (In Vitro and In Vivo Studies) (A
DUBLIN and CHICAGO, May 31, 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 U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. Under the Prescription Drug User Fee Act ("PDUFA"), the FDA has deemed the Company's NDA resubmission to be
Gabelli & Co. upgraded Iterum Therapeutics from Sell to Hold
HC Wainwright & Co. downgraded Iterum Therapeutics from Buy to Neutral
Gabelli & Co upgraded Iterum Therapeutics from Sell to Hold
H.C. Wainwright upgraded Iterum Therapeutics from Neutral to Buy and set a new price target of $2.50
HC Wainwright resumed coverage of Iterum Therapeutics with a rating of Hold
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DUBLIN, Ireland and CHICAGO, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM) (the "Company" or "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 announced the appointment of Sailaja Puttagunta, M.D., to the newly created position of Chief Medical Officer, where she will oversee global clinical development and regulatory initiatives for Iterum. "We are thrilled that Sailaja is back at Iterum given her strong industry and operational leadership at a time when oral sulopenem is re-entering the clin
Patrick Heron to leave the Board DUBLIN, Ireland and CHICAGO, March 16, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “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 announced the appointment of Beth P. Hecht to the Company’s Board of Directors replacing Patrick Heron, who announced he would be leaving the Board, effective as of March 12, 2021. Ms. Hecht will also serve as a member of the Audit Committee and Compensation Committee of the Board. “I want to thank Patrick for his leade
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