Welcome to our dedicated page for Iterum Therapeutics Plc news (Ticker: ITRM), a resource for investors and traders seeking the latest updates and insights on Iterum Therapeutics Plc stock.
Iterum Therapeutics plc (Nasdaq: ITRM) is a pharmaceutical company focused on next generation oral and IV antibiotics designed to treat infections caused by multi-drug resistant pathogens in community and hospital settings. Its news flow centers on the development, approval and commercialization of sulopenem-based therapies, particularly the oral product ORLYNVAH™.
Company press releases highlight regulatory milestones, including U.S. Food and Drug Administration approval of ORLYNVAH™ (oral sulopenem) for adult women with uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis who have limited or no alternative oral antibacterial options. News items also cover the U.S. commercial launch of ORLYNVAH™ and its rollout into the community market through a commercialization partnership with EVERSANA Life Science Services, LLC.
Investors and observers following ITRM news will see updates on market access and reimbursement, such as contracts with group purchasing organizations working with major pharmacy benefit managers (PBMs), rebate agreements with Medicare Part D PBMs, and coverage developments across commercial, Medicare and government plans. Additional coverage includes specialty distribution arrangements with McKesson and Cencora, which enable physicians to obtain ORLYNVAH™ through preferred channels.
Iterum’s news stream also features patent estate developments in regions such as China, Mexico, Canada, Europe and Japan, as well as scientific presentations at conferences like IDWeek and publication of Phase 3 trial data in NEJM Evidence. Financial result announcements, at-the-market equity offering updates and Nasdaq listing compliance notices provide further context on the company’s capital markets activity.
For those tracking Iterum Therapeutics, the ITRM news page offers a consolidated view of clinical, regulatory, commercial, intellectual property and listing-related announcements that shape the company’s progress in the anti-infective space.
Iterum Therapeutics (Nasdaq: ITRM) reported its financial results for Q4 and full year 2022, showing a net loss of $5.1 million for Q4 and $44.4 million for the entire year, improving from a net loss of $4.2 million and $91.6 million in 2021. The company focuses on developing oral and IV antibiotics to combat multi-drug resistant infections. Enrollment in the REASSURE clinical trial for uUTI treatment is ongoing, with an interim analysis expected later in 2023. Cash reserves as of December 31, 2022, stand at $60.8 million, projected to sustain operations until mid-2024. The company also received two new patents extending its portfolio until at least 2039.
Iterum Therapeutics, a clinical-stage pharmaceutical company, will announce its Q4 and full-year 2022 financial results before the U.S. markets open on March 16, 2023. Management will host a conference call at 8:30 a.m. ET to discuss the results and provide a business update. Sulopenem, Iterum's lead compound, is in Phase 3 clinical development and has received QIDP and Fast Track designations for multiple indications. Investors can access the call via dial-in or audio webcast through the company's website.
Iterum Therapeutics plc (Nasdaq: ITRM) announced a Notice of Allowance from the USPTO for its patent on the combination of sulopenem etzadroxil and probenecid, aimed at treating uncomplicated urinary tract infections.
This new patent, set to expire in April 2039, strengthens Iterum's position in the market for oral antibiotics, following a recently issued patent covering the bilayer tablet formulation. The company is currently enrolling patients in a Phase 3 clinical trial for oral sulopenem and anticipates updates after reaching 50% enrollment.
Iterum Therapeutics plc (Nasdaq: ITRM) announced its third-quarter financial results for 2022, reporting a net loss of $29.1 million compared to a net income of $3.7 million in 2021. The company initiated the REASSURE clinical trial for oral sulopenem, targeting uncomplicated urinary tract infections, with enrollment expected to conclude by mid-2024. Iterum's cash position stands at $64.3 million, projected to sustain operations into 2024. A new patent for oral sulopenem was issued, extending protection until 2039. The company also regained compliance with NASDAQ's minimum bid price requirement following a reverse stock split.
Iterum Therapeutics plc (Nasdaq: ITRM) announced that it will release its third quarter 2022 financial results on November 10, 2022, before U.S. market opening. A conference call will follow at 8:30 a.m. ET for discussing these results and business updates. The Company is progressing its lead product, sulopenem, a novel anti-infective in Phase 3 clinical development, demonstrating effectiveness against multi-drug resistant pathogens. Iterum has secured QIDP and Fast Track designations for sulopenem across seven indications.
Iterum Therapeutics announced the dosing of the first patient in its Phase 3 clinical trial, REASSURE, for oral sulopenem aimed at treating uncomplicated urinary tract infections (uUTI) caused by resistant pathogens. This trial compares oral sulopenem to Augmentin and is being conducted under an FDA Special Protocol Assessment. Successful completion of the trial could lead to a resubmission of the new drug application (NDA) in late 2024. The trial is expected to enroll approximately 1,966 patients.
Iterum Therapeutics plc (Nasdaq: ITRM) announced the presentation of two posters at IDWeek 2022, addressing critical advancements in tackling multi-drug resistant infections. The studies include data on the impact of asymptomatic bacteriuria in UTI treatment, and the efficacy of sulopenem against Bacillus anthracis. The conference runs from October 19-23 in Washington, D.C., with poster presentations scheduled for October 20 and 22. These findings will eventually be accessible on the company's website, emphasizing Iterum's commitment to developing novel antibiotics.
Iterum Therapeutics (Nasdaq: ITRM) received a Notice of Allowance from the U.S. Patent Office for patent application number 16/972,300, enhancing protection for its lead candidate, oral sulopenem. This patent extends protection until at least 2039, crucial for its commercial potential. Oral sulopenem aims to be the first oral penem in the U.S. and the first new treatment for uncomplicated urinary tract infections in over two decades. The company is preparing for a pivotal Phase 3 clinical trial expected to begin soon.
Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company, announced its participation in the H.C. Wainwright 24th Annual Hybrid Global Investment Conference on September 14, 2022, at 12:00 PM (ET). CEO Corey Fishman and CFO Judy Matthews will present a company overview and business update. Investor meetings are scheduled for September 13-14, 2022. The presentation will be accessible for 90 days on the company's website under the 'Investors' section. Iterum focuses on developing innovative antibiotics like sulopenem, which is in Phase 3 clinical development.
Iterum Therapeutics (Nasdaq: ITRM) announced it has regained compliance with Nasdaq's minimum bid price requirement after its shares maintained a closing bid price of over $1.00 for ten consecutive trading days, as of August 31, 2022. Previously, the company faced non-compliance issues that began in September 2021, receiving extensions to meet the requirement. Now, Iterum is in compliance with all listing standards and will continue to trade on the Nasdaq Capital Market.