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) announced it received a Complete Response Letter (CRL) from the FDA regarding its NDA for oral sulopenem. The FDA determined that additional data is needed to support approval for treating urinary tract infections after acknowledging positive Phase 3 trial results. The company plans to discuss the CRL with the FDA and may conduct further clinical trials. Iterum has $100.5 million in cash and believes it can fund operations into the second half of 2023.
Iterum Therapeutics (Nasdaq: ITRM) announced it received a letter from the FDA regarding deficiencies in its New Drug Application (NDA) for sulopenem etzadroxil/probenecid. This letter halts discussions about labeling and post-marketing commitments but does not denote a final decision. The PDUFA goal date for the NDA review is July 25, 2021. CEO Corey Fishman expressed disappointment but affirmed the commitment to resolve issues with the FDA expediently. Sulopenem aims to address antibiotic resistance and has received Fast Track designations in several indications.
The Company Iterum Therapeutics plc (Nasdaq: ITRM) announced its participation in a late-cycle meeting with the FDA regarding its NDA for sulopenem etzadroxil/probenecid, aimed at treating uncomplicated urinary tract infections. The FDA is still reviewing the application and has indicated that an Advisory Committee meeting is not necessary. The PDUFA date is set for July 25, 2021. Iterum is developing sulopenem, which has shown efficacy against drug-resistant pathogens, and holds QIDP and Fast Track designations for multiple indications.
Iterum Therapeutics plc (Nasdaq: ITRM) announced ongoing FDA review of its NDA for oral sulopenem aimed at treating uncomplicated urinary tract infections, with a PDUFA date set for July 25, 2021. The company reported a cash position of $100.5 million, expected to fund operations into the first half of 2023. First-quarter 2021 net loss surged to $98.9 million, largely due to non-cash adjustments, while R&D expenses decreased significantly to $2.5 million. Iterum has partnered with EVERSANA for commercialization efforts, anticipating a product launch in Q4 2021, pending FDA approval.
Iterum Therapeutics plc (Nasdaq: ITRM) will announce its first quarter 2021 financial results on May 14, 2021, before U.S. market open. A conference call is scheduled for 8:30 a.m. ET to discuss these results and provide business updates. The company focuses on developing next-generation antibiotics to combat multi-drug resistant infections, with its lead compound, sulopenem, in Phase 3 clinical development. Sulopenem has received Qualified Infectious Disease Product and Fast Track designations in seven indications.
Iterum Therapeutics (Nasdaq: ITRM) announced that CEO Corey Fishman will present a business update at the 20th Annual Needham Virtual Healthcare Conference on April 15, 2021, at 3:45 PM ET. The company is focused on developing oral and IV antibiotics to combat multi-drug resistant infections. Iterum is advancing sulopenem, which has shown effectiveness against resistant bacteria and received QIDP and Fast Track designations for multiple indications. For more details, visit the company’s website.
Iterum Therapeutics announces the appointment of Beth P. Hecht to its Board of Directors, replacing Patrick Heron effective March 12, 2021. Hecht brings over 25 years of experience in the life sciences sector, including her role as SVP and General Counsel at Xeris Pharmaceuticals. CEO Corey Fishman expressed confidence in Hecht's ability to guide the company as it transitions from a developmental to a commercial organization, particularly in bringing its first branded oral antibiotic for uncomplicated urinary tract infections to market.
Iterum Therapeutics (ITRM) reported Q4 and full-year 2020 financial results, highlighting notable progress on its NDA for oral sulopenem intended for urinary tract infections. The FDA's PDUFA goal date is set for July 25, 2021. The company has extended its cash runway into the first half of 2023 due to proceeds of $74.3 million from recent offerings. R&D expenses decreased significantly to $21.1 million from $90.8 million a year earlier. Iterum's net loss for 2020 narrowed to $52.0 million from $103.1 million in 2019. A conference call is scheduled for today at 8:30 am ET.
Iterum Therapeutics (Nasdaq: ITRM) is set to announce its fourth quarter and full year 2020 financial results on March 12, 2021, before the U.S. market opens. A conference call will follow at 8:30 a.m. ET for management to discuss the outcomes. Iterum is focused on developing antibiotics like sulopenem, which is in Phase 3 trials to combat multi-drug resistant pathogens. The company has received QIDP and Fast Track designations for sulopenem's formulations across seven indications.
Iterum Therapeutics, a clinical-stage pharmaceutical company, announced that CEO Corey Fishman will present at key investor conferences, including the SVB Leerink Annual Global Healthcare Conference on February 25, 2021, and the HC Wainwright Global Life Sciences Conference starting March 9, 2021. The company is focusing on its lead compound, sulopenem, in Phase 3 clinical trials for treating infections caused by multi-drug resistant pathogens. Sulopenem has received Fast Track and Qualified Infectious Disease Product designations for various indications.
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