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Iterum Therapeutics plc Ordinary Share - ITRM STOCK NEWS

Welcome to our dedicated page for Iterum Therapeutics plc Ordinary Share news (Ticker: ITRM), a resource for investors and traders seeking the latest updates and insights on Iterum Therapeutics plc Ordinary Share stock.

Iterum Therapeutics plc (Nasdaq: ITRM) is an Ireland-based clinical-stage pharmaceutical company committed to developing unique anti-infectives to address the global crisis of multi-drug resistant (MDR) pathogens. The company's flagship product, sulopenem, is a novel penem anti-infective available in both oral and intravenous formulations. Sulopenem has shown potent in-vitro activity against a wide range of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics.

Currently, Iterum is focused on advancing sulopenem through Phase 3 clinical development. The company recently completed its REASSURE trial—a critical study comparing oral sulopenem to oral Augmentin® in adult women with uncomplicated urinary tract infections (uUTIs). The trial demonstrated that oral sulopenem was non-inferior to Augmentin® for the primary efficacy endpoint, with statistically significant superiority in overall success rates.

Iterum has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for sulopenem in seven indications from the U.S. Food and Drug Administration (FDA). The company recently resubmitted its New Drug Application (NDA) for oral sulopenem, which has been accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) action date set for October 25, 2024.

Financially, Iterum reported robust research and development (R&D) expenditures, primarily driven by the REASSURE trial. The company’s net loss decreased in 2023 compared to the previous year, reflecting its focused investment in key clinical trials and strategic projects.

Iterum is actively seeking partnerships and strategic options to maximize the value of sulopenem, including potential sales or licensing agreements. The firm's dedicated efforts in combating MDR pathogens aim to significantly improve the lives of people affected by serious and life-threatening diseases.

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Iterum Therapeutics announced two data presentations at the IDSA IDWeek™ 2020 from October 21-25, covering results from the SURE-1 and SURE-2 trials for urinary tract infections. The SURE-1 trial demonstrated that oral sulopenem was statistically superior to oral ciprofloxacin in treating uncomplicated urinary tract infections (uUTI). Results from both trials will be presented by Michael Dunne, showing the comparative efficacy and safety of sulopenem against existing treatments for complicated and uncomplicated infections.

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Iterum Therapeutics announced two upcoming data presentations at the IDWeek™ 2020, set for October 21-25, 2020. This includes findings from the SURE-1 trial demonstrating oral sulopenem's effectiveness against uncomplicated urinary tract infections (uUTI) compared to oral ciprofloxacin, deemed statistically superior. Additionally, results from the SURE-2 trial on complicated urinary tract infections (cUTI) will be shared. The company is progressing with sulopenem as a novel anti-infective aimed at combating antibiotic resistance.

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Iterum Therapeutics has announced plans to submit a New Drug Application (NDA) for sulopenem etzadroxil/probenecid, a treatment for uncomplicated urinary tract infections caused by quinolone-resistant pathogens. Following a positive pre-NDA meeting with the FDA, the company has received confidence regarding the submission's requirements. Over 6 million quinolone-resistant urinary tract infections occur annually in the U.S., and sulopenem has shown effectiveness exceeding ciprofloxacin. The company has been granted Fast Track and Qualified Infectious Disease Product designations for sulopenem.

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Iterum Therapeutics (Nasdaq: ITRM) plans to submit a New Drug Application (NDA) for sulopenem etzadroxil/probenecid, aimed at treating uncomplicated urinary tract infections caused by quinolone-resistant pathogens. Following a pre-NDA meeting with the FDA, Iterum is confident about its submission strategy. Each year, over 6 million quinolone-resistant UTIs occur in the U.S. The NDA follows sulopenem's proven superiority over ciprofloxacin in clinical settings. The company’s innovative approach addresses the growing crisis of multi-drug resistant infections.

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Iterum Therapeutics announced its participation in the 22nd Annual H.C. Wainwright Global Investment Conference, taking place virtually from September 14 – 16, 2020. CEO Corey Fishman will present an overview of the company on September 16, 2020, at 10:00 a.m. ET. The company is dedicated to developing antibiotics to combat multi-drug resistant pathogens, focusing on its lead compound, sulopenem, currently in Phase 3 clinical development. Iterum has received QIDP and Fast Track designations for sulopenem in seven indications.

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Iterum Therapeutics plc (Nasdaq: ITRM) announced the expiration of its rights offering subscription period on August 31, 2020. The offering allowed rights holders to purchase units consisting of Exchangeable Senior Subordinated Notes and Limited Recourse Royalty-Linked Subordinated Notes. The company reported preliminary results with 6,374 units subscribed, estimating gross proceeds of approximately $6.37 million, excluding estimated expenses of $1.5 million. Settlement is expected around September 8, 2020. The offering was linked to a prior private placement involving new securities.

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Iterum Therapeutics plc (Nasdaq: ITRM) reported its Q2 2020 financial results, highlighting a net loss of $12.5 million, a significant improvement from the $27.6 million loss in Q2 2019. Cash and cash equivalents stood at $12.3 million, supplemented by $4.4 million from a registered direct offering in July 2020. The company achieved one primary endpoint in its uUTI trial but failed in its cUTI trial. A meeting with the FDA is scheduled for Q3 2020 to discuss regulatory options for sulopenem. Overall R&D expenses dropped to $5.0 million, reflecting reduced clinical trial activities.

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Iterum Therapeutics plc (Nasdaq: ITRM) announced a planned rights offering to raise up to $8.4 million, following a private placement of senior subordinated notes. The record date for the rights offering is set for August 5, 2020. Each eligible shareholder will receive one non-transferable subscription right per ordinary share owned, allowing them to purchase up to 8,400 units at a subscription price of $1,000 per unit. The subscription period is expected to start on August 11, 2020, lasting at least 20 days. Details will follow after the SEC registration statement becomes effective.

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Iterum Therapeutics has entered into agreements for the purchase of 3,372,686 ordinary shares at $1.4825 each in a registered direct offering, totaling approximately $5.0 million. Concurrently, unregistered warrants to purchase up to 1,686,343 ordinary shares will be issued with an exercise price of $1.42 per share. Proceeds will support continued clinical development of sulopenem and general corporate purposes. The offering is set to close around July 2, 2020, pending customary conditions.

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Iterum Therapeutics plc (Nasdaq: ITRM) announced the successful passing of all resolutions at its Annual General Meeting on June 10, 2020. A significant resolution allowed Sarissa Capital Management's funds to potentially acquire up to 60% of the company's ordinary shares through the exchange of $15 million of Exchangeable Senior Subordinated Notes. The resolution received 6,808,330 votes in favor and 199,749 against. The Sarissa Notes could result in the issuance of approximately 15 million new shares.

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FAQ

What is the current stock price of Iterum Therapeutics plc Ordinary Share (ITRM)?

The current stock price of Iterum Therapeutics plc Ordinary Share (ITRM) is $2.7 as of December 6, 2024.

What is the market cap of Iterum Therapeutics plc Ordinary Share (ITRM)?

The market cap of Iterum Therapeutics plc Ordinary Share (ITRM) is approximately 77.1M.

What is Iterum Therapeutics plc?

Iterum Therapeutics plc is a clinical-stage pharmaceutical company focused on developing anti-infectives to combat multi-drug resistant pathogens.

What is sulopenem?

Sulopenem is Iterum Therapeutics' novel anti-infective compound, available in oral and intravenous forms, aimed at treating infections caused by antibiotic-resistant bacteria.

What recent achievements has Iterum Therapeutics made?

Iterum recently completed the REASSURE Phase 3 clinical trial, which demonstrated the efficacy of oral sulopenem. The company also resubmitted its NDA to the FDA, which has been accepted for review.

What is the REASSURE trial?

The REASSURE trial is a Phase 3 clinical study comparing oral sulopenem to oral Augmentin® in adult women with uncomplicated urinary tract infections, demonstrating non-inferiority and statistically significant superiority.

What designations has sulopenem received from the FDA?

Sulopenem has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations in seven indications.

When is the FDA's PDUFA action date for sulopenem?

The PDUFA action date for the resubmitted NDA for oral sulopenem is October 25, 2024.

What are Iterum Therapeutics' financial highlights?

Iterum's R&D expenses have increased due to its clinical trials, but the net loss has decreased compared to the previous year, demonstrating focused investment in key projects.

What strategic options is Iterum Therapeutics exploring?

Iterum is evaluating strategic partnerships, sales, or licensing agreements to maximize the value of sulopenem.

How does sulopenem address antibiotic resistance?

Sulopenem has demonstrated potent activity against a wide variety of bacteria resistant to other antibiotics, offering a potential solution to the growing problem of antibiotic resistance.

Where can I find more information about Iterum Therapeutics?

For more information, please visit Iterum Therapeutics' official website at www.iterumtx.com.

Iterum Therapeutics plc Ordinary Share

Nasdaq:ITRM

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