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.

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NEW YORK, July 7, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Iterum Therapeutics plc ("Iterum" or the "Company") (NASDAQ: ITRM). Such investors are advised to contact Robert S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Iterum Therapeutics plc (ITRM)

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Iterum looked to be on track for a July 25 PDUFA for its first commercial drug, sulopenem. Now, the company faces uncertainty as the FDA has issued a letter seeking labeling clarification.

Despite Risks Around Regulatory Approval, Iterum Therapeutics Rates A Speculative Buy

A lack of clarity and final decision in the U.S. Food and Drug Administration's (FDA) recent letter to Iterum Therapeutics PLC (NASDAQ:ITRM) failed to deter H.C. Wainwright & Co's bullish sentiment on Iterum stock.

Iterum Therapeutics Analyst Remains Bullish Despite Concerns Over FDA Letter

The company received disappointing news from the FDA.

Why Iterum Therapeutics Stock Is Crashing Today

The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) fell by over 39% pre-market. This is why it happened.

ITRM Stock Price Falls Over 39% Pre-Market: Why It Happened

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The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) increased by 7.73% after hours on Friday, June 25. This is why it happened.

ITRM Stock Price Increased 7.73% After Hours: Why It Happened

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Why Iterum Therapeutics Stock Soared Today

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Iterum Therapeutics plc (NASDAQ: ITRM) has concluded a late-cycle meeting with the FDA related to its application for sulopenem etzadroxil/probenecid. Sulopenem is under review as a treatment for uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.

Iterum Therapeutics Stock Shoots Higher As Sulopenem Application Review On Track

DUBLIN, Ireland and CHICAGO, May 27, 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 participated in a late-cycle meeting with the U.S. Food and Drug Administration (“FDA”) yesterday. During the meeting, the FDA shared issues still under review regarding the Company's new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and the Company responded to these issues. The FDA has determined that an Advisory Committee meeting is not currently necessary. The review of the NDA is ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021.

Iterum Therapeutics Provides Update on NDA Review

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Iterum Therapeutics plc (ITRM) CEO Corey Fishman on Q1 2021 Results - Earnings Call Transcript

FDA Review of NDA for Oral Sulopenem Continues; Current Prescription Drug User Fee Act (PDUFA) date of July 25, 2021

Iterum Therapeutics Reports First Quarter 2021 Financial Results

DUBLIN, Ireland and CHICAGO, May 07, 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 first quarter 2021 financial results before the open of the U.S. financial markets on Friday, May 14, 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.

Iterum Therapeutics to Provide Business Update and Report First Quarter 2021 Financial Results on May 14, 2021

Iterum Therapeutics plc is a small late-clinical-stage pharmaceutical company developing Sulopenem, their lead and sole therapeutic for urinary tract and intra-abdominal infections. Iterum has tested their sole candidate Sulopenem in 3 simultaneous Phase 3 trials, but none met their primary endpoints, except for a subpopulation of uUTI patients with a quinolone non-susceptible pathogen.

Iterum Therapeutics: Delayed Review Of Its NDA For Sulopenem, But Upside Still Exists

News for Iterum Therapeutics Plc Stock (ITRM)