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) 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.
Iterum Therapeutics plc (Nasdaq: ITRM) announced the successful closure of its public offering of ordinary shares, with the underwriter fully exercising its option to purchase an additional 5,217,391 shares. This brings the total shares sold to 40,000,000, generating net proceeds of approximately $42.1 million. The funds are projected to sustain operations through mid-2023, covering expenses until the PDUFA goal date of July 25, 2021, for the FDA's review of sulopenem. The offering is registered under Form S-3 with the SEC and includes forward-looking statements about the company's financial outlook.
Iterum Therapeutics plc (Nasdaq: ITRM) announced a definitive agreement to sell 17,500,000 ordinary shares at $2.00 each in a registered direct offering, expected to close by February 12, 2021. The offering is projected to generate approximately $35.0 million in gross proceeds. The funds will be allocated for ongoing NDA review for oral sulopenem, pre-commercialization activities, continued clinical development, and general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for this transaction.
Iterum Therapeutics plc (Nasdaq: ITRM) has announced an increase in its public offering to 34,782,609 ordinary shares at $1.15 each, aiming to raise approximately $40 million. The funds will support the New Drug Application review for oral sulopenem, pre-commercialization, and operational expenses. The offering closes around February 8, 2021, pending customary conditions. With this offering, Iterum anticipates its funds will last into Q3 2022, covering expenses until the FDA's review completion date of July 25, 2021.
Iterum Therapeutics plc (Nasdaq: ITRM) announced an underwriting agreement with H.C. Wainwright & Co. to sell 8,695,653 ordinary shares at $1.15 each, potentially raising approximately $10 million. An additional 1,304,347 shares may be purchased by the underwriter. Proceeds will primarily support the review of its New Drug Application for oral sulopenem, pre-commercialization activities, and working capital. The offering is expected to close around February 8, 2021. The company anticipates sufficient funds to support operations into Q1 2022, but warns of inherent risks to projections.
Iterum Therapeutics (Nasdaq: ITRM) announced a partnership with EVERSANA™ to initiate pre-launch activities for its oral sulopenem, targeting uncomplicated urinary tract infections (uUTIs). The FDA accepted the New Drug Application (NDA) for sulopenem, with a priority review and a PDUFA date set for July 25, 2021. The collaboration aims to enhance market access, strategic marketing, and medical education, preparing for a potential late 2021 launch. The CEO expressed confidence in EVERSANA's capabilities to support an effective launch of this antibiotic aimed at combating multi-drug resistant pathogens.
Iterum Therapeutics announced that the FDA accepted its New Drug Application for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs). This application has been designated for priority review, with a PDUFA goal date of July 25, 2021. If approved, sulopenem would be the first oral penem in the U.S. and the first new treatment for uUTIs in over 20 years, addressing the issue of quinolone resistance in millions of U.S. cases annually. The NDA includes positive data from Phase 3 clinical trials demonstrating superior efficacy compared to ciprofloxacin.
Dublin-based Iterum Therapeutics plc (Nasdaq: ITRM) is set to participate in the virtual H.C. Wainwright BioConnect Conference from January 11-14, 2021. CEO Corey Fishman will present a company overview and business update, available on-demand starting January 11 at 6:00 a.m. Eastern Time. Iterum focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens. Their leading compound, sulopenem, is in Phase 3 clinical development and has received Fast Track and QIDP designations for its oral and IV formulations in seven indications.
On December 21, 2020, Iterum Therapeutics announced the resignation of Chief Scientific Officer Dr. Michael Dunne, who will continue as a strategic advisor and board member. Dr. Steve Aronin, Senior Vice President and Head of Clinical Development, will assume leadership of development and regulatory activities. The company submitted its New Drug Application (NDA) for oral sulopenem to the FDA in November 2020, aiming for a decision in Q3 2021. Iterum is focused on combating multi-drug resistant infections.