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 has submitted a New Drug Application (NDA) to the FDA for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) caused by quinolone non-susceptible pathogens. This submission is pivotal, as it could introduce the first oral penem antibiotic in the U.S. in over two decades. The NDA includes successful data from three phase 3 clinical trials, showing oral sulopenem's superiority over ciprofloxacin. If approved, it could address the needs of over 6 million patients annually suffering from cipro-resistant UTIs.
Iterum Therapeutics (Nasdaq: ITRM) reported its Q3 2020 financial results, highlighting the imminent NDA filing for oral sulopenem to treat uncomplicated urinary tract infections (uUTIs). The company received positive FDA feedback at their September pre-NDA meeting and anticipates market introduction of this novel therapy within the next three quarters. They raised $17.4 million in October, extending their cash runway into Q3 2021. Q3 net loss decreased to $12.2 million, down from $31.3 million in 2019, while R&D expenses significantly fell to $3.9 million from $28.1 million year-over-year.
Iterum Therapeutics (Nasdaq: ITRM) announced a public offering of 26,923,076 ordinary shares at $0.65 per share, alongside warrants for 20,192,307 shares. The offering, expected to close on October 27, 2020, aims to raise approximately $17.5 million for its clinical initiatives, including the New Drug Application for oral sulopenem targeting urinary tract infections linked to quinolone-resistant pathogens. H.C. Wainwright & Co. acts as the exclusive placement agent. The offering is registered under Form S-1 with the SEC, effective October 22, 2020.
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.
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.
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.
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.
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.
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.
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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