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) has announced its participation in the ASM Microbe 2024 conference in Atlanta, Georgia, from June 13-17, 2024. The company will present a poster titled 'In Vitro Assessment of Sulopenem against Mycobacterium avium Complex' on June 16, 2024, from 10:00 a.m. to 4:00 p.m. in the Exhibit Hall. The presentation falls under the category of 'New Antimicrobial Agents' and will be delivered by Dr. Steven I. Aronin. The poster will be available on Iterum Therapeutics' website after the conference.
Iterum Therapeutics announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) in adult women. The FDA has assigned a PDUFA action date of October 25, 2024. This milestone follows the REASSURE clinical trial, which showed that oral sulopenem was non-inferior to Augmentin® and even demonstrated statistically significant superiority in overall success rate. The FDA's acceptance marks a critical step towards potentially providing a new treatment option for uUTIs, addressing a significant unmet medical need.
Iterum Therapeutics reported its first quarter 2024 financial results, highlighting the resubmission of its NDA for oral sulopenem. The company expects FDA action in early Q4 2024. With cash runway into 2025, Iterum sold 3 million shares for net proceeds of $7.2 million. The company's current cash position is expected to fund operations through 2025.
Iterum Therapeutics plc (Nasdaq: ITRM) will report its first quarter 2024 financial results on May 13, 2024. The company focuses on developing oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens. A conference call will be held to discuss financial results and business updates.
Iterum Therapeutics has resubmitted its New Drug Application for oral sulopenem to the U.S. FDA for the treatment of uncomplicated urinary tract infections. The potential approval of oral sulopenem, the first oral penem in the U.S. and the second new oral treatment for uUTIs in over 25 years, could benefit an estimated 40 million women suffering from uUTIs annually in the U.S. The NDA resubmission includes data from phase 3 clinical trials showing oral sulopenem's efficacy and safety, positioning it as a promising new antibiotic option.
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