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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) will release its Q3 2021 financial results on November 12, 2021, before U.S. markets open. A conference call will occur at 8:30 a.m. ET to discuss these results and provide a business update. The company focuses on developing antibiotics to combat multi-drug resistant pathogens. Its leading compound, sulopenem, is currently in Phase 3 clinical development, with both oral and IV formulations receiving Fast Track and QIDP designations. For more details, visit iterumtx.com.
Iterum Therapeutics (Nasdaq: ITRM) announced a productive Type A meeting with the FDA regarding the New Drug Application for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs). Following a Complete Response Letter (CRL) from the FDA for additional data, the company is exploring options for a new Phase 3 study. As of Q2 2021, Iterum has $91.5 million in cash, sufficient to support operations into H2 2023. The company continues to pursue solutions for addressing multi-drug resistant UTIs through its anti-infective research.
Iterum Therapeutics plc (Nasdaq: ITRM) announced a data presentation at the IDWeek 2021, taking place virtually from September 29 to October 3, 2021. The presentation, titled In Vitro Antibacterial Susceptibility Testing of Sulopenem Against Category A and B Bio-threat Bacterial Pathogens, will feature lead author Steven I. Aronin and is scheduled for September 29, 2021, during the Novel Agents poster session.
Iterum is focused on developing novel oral and IV antibiotics, particularly sulopenem, which has shown potent activity against multi-drug resistant pathogens and has received QIDP and Fast Track designations.
Bernstein Liebhard, an investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a class action lawsuit for Iterum Therapeutics (ITRM). The lawsuit claims that Iterum made misleading statements regarding its sulopenem NDA for treating urinary tract infections, impacting its stock performance. Following FDA correspondence indicating deficiencies in the NDA, Iterum's stock fell significantly. Investors must act by October 4, 2021, to participate in the lawsuit.
DUBLIN, Ireland and CHICAGO, Sept. 08, 2021 -- Iterum Therapeutics plc (Nasdaq: ITRM) announced that CEO Corey Fishman will present a company overview at the H.C. Wainwright 23rd Annual Virtual Global Investment Conference. The presentation will be available on-demand starting September 13 at 7:00 A.M. (ET). Iterum is focused on developing next-generation antibiotics, including sulopenem, targeting multi-drug resistant pathogens. The company has received QIDP and Fast Track designations for sulopenem in seven indications. For more information, visit www.iterumtx.com.
Iterum Therapeutics (ITRM) reported its Q2 2021 financial results, noting a net income of $7.8 million, significantly improved from a net loss of $12.5 million in Q2 2020. The increase is attributed to a non-cash adjustment related to its Royalty-Linked Notes. Following an FDA Complete Response Letter in July, Iterum is preparing for a Type A meeting with the FDA regarding the approval pathway for oral sulopenem, anticipated by late Q3 2021. The company maintains a strong cash position, with $91.4 million on hand, sufficient to fund operations into the second half of 2023.
Iterum Therapeutics (Nasdaq: ITRM) has announced its second quarter 2021 financial results will be released on August 13, 2021, before U.S. market opening. The management will hold a conference call at 8:30 a.m. ET to discuss the results and business updates. The company, focused on developing antibiotics for multi-drug resistant infections, is advancing its lead compound, sulopenem, through Phase 3 clinical development. Sulopenem has received QIDP and Fast Track designations in seven indications, highlighting its potential market impact.
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.
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