Iterum Therapeutics Plc

Iterum Therapeutics Plc operates as a pharmaceutical company, which engages in the development and commercialization of sulopenem to be potentially the first and only oral and intravenous branded penem available. The company was founded by Corey N. Fishman on June 24, 2015 and is headquartered in Dublin, Ireland.

Earnings data Q4 2020

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Iterum Therapeutics progresses with sulopenem, faces regulatory challenges

Iterum Therapeutics (ITRM) showcased progress in key areas like FDA interactions, patent approvals, and maintaining a strong financial position.
While challenges exist in regulatory approval and funding, the company's strategic vision and commitment to growth offer opportunities for success.
Overall, Iterum's focus on advancing sulopenem for uncomplicated UTIs and engaging with the FDA reflects a promising trajectory for future growth.

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Iterum Therapeutics Plc operates as a pharmaceutical company, which engages in the development and commercialization of sulopenem. The company was founded by Corey N. Fishman on June 24, 2015 and is headquartered in Dublin, Ireland.

Iterum Therapeutics plc (NASDAQ:ITRM ) U.S. FDA Approval of ORLYNVAH October 28, 2024 8:30 AM ET Company Participants Louise Barrett - SVP, Legal Affairs & Secretary Corey Fishman - President, Director & CEO Steven Aronin - SVP & Head, Clinical Development Conference Call Participants Operator Hello, everyone, and welcome to Iterum Therapeutics call to discuss the recent approval of ORLYNVAH the treatment of Uncomplicated UTIs. My name is Lydia, and I'll be your operator today.

Iterum Therapeutics plc (ITRM) U.S. FDA Approval of ORLYNVAH Call (Transcript)

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.

Iterum Therapeutics to Host Morning Conference Call on U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

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

Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

The U.S. Food and Drug Administration has approved Iterum Therapeutics' oral antibiotic to treat a type of urinary tract infection (UTI) in adult women, the health regulator said on Friday.

US FDA approves Iterum's treatment for urinary infection

DUBLIN and CHICAGO, Oct. 10, 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 three posters will be presented at the Infectious Disease Society of America's IDWeek 2024 conference taking place in Los Angeles, CA from October 16-19, 2024.

Iterum Therapeutics to Present Data at IDWeek 2024

DUBLIN and CHICAGO, Oct. 09, 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 it will participate in the 2024 Maxim Healthcare Virtual Summit. Corey Fishman, CEO of Iterum, will join Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group, for a Fireside Chat at 10:00 a.m. ET on October 16, 2024.

Iterum Therapeutics to Participate at the 2024 Maxim Healthcare Virtual Summit

Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.

ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down

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.

Iterum Therapeutics to Present at the 26th Annual H.C. Wainwright Global Investment Conference

Iterum Therapeutics plc (NASDAQ:ITRM ) Q2 2024 Results Conference Call August 14, 2024 8:30 AM ET Company Participants Louise Barrett - Senior Vice President of Legal Affairs & Secretary Corey Fishman - President, CEO & Director Judith Matthews - Chief Financial Officer Conference Call Participants Jason McCarthy - Maxim Group Operator Good morning, everyone. Welcome to Iterum Therapeutics Second Quarter 2024 Financial Results and Business Update.

Iterum Therapeutics plc (ITRM) Q2 2024 Earnings Call Transcript

- - 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.

Iterum Therapeutics Reports Second Quarter 2024 Financial Results

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.

Iterum Therapeutics to Report Second Quarter 2024 Financial Results on August 14, 2024

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 not waived (each, an “eligible warrant holder” and collectively, the “eligible warrant holders”) as of 5:00 p.m., Eastern Time, on July 16, 2024 (the “Record Date”).

Iterum Therapeutics Announces Expiration and Results of Rights Offering

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).

Iterum Therapeutics Broadens Patent Estate for Oral Sulopenem

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”).

Iterum Therapeutics Commences Rights Offering

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 discuss a) antimicrobial stewardship issues raised by potential approval and subsequent use of what would be the first oral penem in the U.S.; and b) the most appropriate target patient population(s) for treatment of uUTI with sulopenem etzadroxil/probenecid. The proposed date for the Advisory Committee meeting is September 9, 2024.

Iterum Therapeutics Announces FDA Advisory Committee Meeting to discuss NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections

Oral Sulopenem NDA has been assigned a PDUFA action date of October 25, 2024 Oral Sulopenem NDA has been assigned a PDUFA action date of October 25, 2024

Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections

Iterum Therapeutics plc (NASDAQ:ITRM ) Q1 2024 Earnings Conference Call May 13, 2024 8:30 AM ET Company Participants Louise Barrett - SVP, Legal Affairs Corey N. Fishman - CEO Judith M.

Iterum Therapeutics plc (ITRM) Q1 2024 Earnings Call Transcript

- -NDA Resubmitted; FDA Action Expected in Early Q4 24-- - -Cash Runway into 2025, including through Potential FDA Approval--

Iterum Therapeutics Reports First Quarter 2024 Financial Results

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.

Iterum Therapeutics to Report First Quarter 2024 Financial Results on May 13, 2024

--First Oral Penem in the U.S. and Second New Oral Treatment for uUTIs in Over 25 Years, if approved-- --Potential Approval Early Q4 2024--

Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem

Iterum Therapeutics plc (ITRM) Q4 2023 Earnings Call Transcript

- -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 completing the new drug application (NDA) for the planned resubmission early in the second quarter,” said Corey Fishman, Iterum's Chief Executive Officer.

Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

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.

Iterum Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on March 28, 2024

DUBLIN, Ireland and CHICAGO, March 15, 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, announced today that the company will participate in a virtual H.C. Wainwright @Home Fireside Chat on March 21, 2024. Corey Fishman, Iterum's Chief Executive Officer, Sailaja Puttagunta, M.D., Iterum's Chief Medical Officer, and Judy Matthews, Iterum's Chief Financial Officer, will discuss Iterum's lead program, oral sulopenem, for the treatment of adult women with uncomplicated urinary tract infections (uUTI).

Iterum Therapeutics to Participate in H.C. Wainwright Virtual @Home Fireside Chat

Iterum (ITRM) stock rises as the company gears up to submit a regulatory application to the FDA seeking approval for oral sulopenem to treat adult women with uUTIs ahead of schedule.

News for Iterum Therapeutics Plc Stock (ITRM)