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Iterum Therapeutics plc (Nasdaq: ITRM) is an Ireland-based clinical-stage pharmaceutical company committed to developing unique anti-infectives to address the global crisis of multi-drug resistant (MDR) pathogens. The company's flagship product, sulopenem, is a novel penem anti-infective available in both oral and intravenous formulations. Sulopenem has shown potent in-vitro activity against a wide range of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics.
Currently, Iterum is focused on advancing sulopenem through Phase 3 clinical development. The company recently completed its REASSURE trial—a critical study comparing oral sulopenem to oral Augmentin® in adult women with uncomplicated urinary tract infections (uUTIs). The trial demonstrated that oral sulopenem was non-inferior to Augmentin® for the primary efficacy endpoint, with statistically significant superiority in overall success rates.
Iterum has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for sulopenem in seven indications from the U.S. Food and Drug Administration (FDA). The company recently resubmitted its New Drug Application (NDA) for oral sulopenem, which has been accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) action date set for October 25, 2024.
Financially, Iterum reported robust research and development (R&D) expenditures, primarily driven by the REASSURE trial. The company’s net loss decreased in 2023 compared to the previous year, reflecting its focused investment in key clinical trials and strategic projects.
Iterum is actively seeking partnerships and strategic options to maximize the value of sulopenem, including potential sales or licensing agreements. The firm's dedicated efforts in combating MDR pathogens aim to significantly improve the lives of people affected by serious and life-threatening diseases.
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.
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.
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