Welcome to our dedicated page for Iterum Therapeutics plc Ordinary Share news (Ticker: ITRM), a resource for investors and traders seeking the latest updates and insights on Iterum Therapeutics plc Ordinary Share stock.
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 (Nasdaq: ITRM) has regained full compliance with Nasdaq listing requirements, resolving its previous deficiency under Listing Rule 5550(b). The company received written confirmation from Nasdaq's Listing Qualifications Staff, and the previously scheduled hearing before the Hearings Panel on November 21 has been cancelled. As a result, Iterum will continue to be traded on The Nasdaq Capital Market. The company focuses on developing next-generation oral and IV antibiotics for treating multi-drug resistant pathogen infections in both community and hospital settings.
Iterum Therapeutics reported Q3 2024 financial results following FDA approval of ORLYNVAH for uncomplicated urinary tract infections on October 25, 2024. The company reported cash and equivalents of $14.5 million as of September 30, 2024. R&D expenses decreased to $3.1 million from $14.9 million in Q3 2023, while G&A expenses remained stable at $1.8 million. Net loss was $6.1 million compared to $3.9 million in the same period last year. ORLYNVAH, the only oral penem antibiotic approved in the U.S., received 10 years of marketing exclusivity under the GAIN Act.
Iterum Therapeutics (Nasdaq: ITRM), a developer of next-generation oral and IV antibiotics for multi-drug resistant pathogens, announced it will release its third quarter 2024 financial results before U.S. markets open on Thursday, November 14, 2024. The company will host a conference call at 8:30 a.m. ET on the same day to discuss financial results and provide a business update. Investors can access the call via phone or audio webcast through the company's website.
Iterum Therapeutics (Nasdaq: ITRM) announces a conference call on October 28, 2024, at 8:30 a.m. EDT to discuss the FDA approval of ORLYNVAH™ (Oral Sulopenem). This groundbreaking treatment for uncomplicated urinary tract infections (uUTIs) marks two significant milestones: it's the first oral penem approved in the U.S. and Iterum's first FDA-approved product. ORLYNVAH™ is specifically approved for adult women with treatment options, targeting infections caused by specific microorganisms. Notably, it represents only the second FDA-approved uUTI treatment in two decades.
Iterum Therapeutics (Nasdaq: ITRM) has received FDA approval for ORLYNVAH™, the first oral penem approved in the U.S. for treating uncomplicated urinary tract infections (uUTIs). The drug is specifically approved for adult women with or no alternative oral antibacterial treatment options against designated microorganisms. The approval is based on two Phase 3 clinical trials, SURE 1 and REASSURE, which demonstrated superiority to ciprofloxacin in fluoroquinolone resistant infections and statistical superiority to Augmentin™ in the susceptible population, respectively. ORLYNVAH™ represents the second FDA-approved treatment for uUTIs in the past two decades.
Iterum Therapeutics (Nasdaq: ITRM) announced its participation in IDWeek 2024, presenting three posters at the conference in Los Angeles from October 16-19, 2024. The presentations focus on the company's oral antibiotic sulopenem and its applications in treating uncomplicated urinary tract infections (uUTI) and inhalational anthrax.
The posters include results from the REASSURE trial on oral sulopenem/probenecid for uUTI, an analysis of asymptomatic bacteriuria in uUTI patients from the same trial, and the efficacy of sulopenem in a rabbit model of inhalational anthrax. All presentations will be given by Dr. Steven I. Aronin on October 18, with specific times and locations provided.
Iterum Therapeutics will make these posters available on their website's 'Publications: Posters & Presentations' page after the conference concludes.
Iterum Therapeutics (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing next-generation oral antibiotics for multi-drug resistant pathogens in community settings, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Corey Fishman will engage in a Fireside Chat with Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group, on October 16, 2024, at 10:00 a.m. ET.
The summit is scheduled from October 15 – 17, 2024, and will be live-streamed on M-Vest. Interested parties can register and access the fireside chat through the provided link: https://m-vest.com/events/healthcare-10152024.
Iterum Therapeutics (Nasdaq: ITRM) provided an update on the FDA Advisory Committee discussion of oral sulopenem for treating uncomplicated urinary tract infections (uUTI) in adult women. The Antimicrobial Drugs Advisory Committee (AMDAC) met on September 9, 2024, to discuss the benefits, risks, and appropriate use of sulopenem etzadroxil/probenecid. The committee acknowledged oral sulopenem as an important treatment option for certain uUTI patients. Iterum presented data from the REASSURE and SURE-1 Phase 3 clinical trials. The FDA's decision on approval is expected by the PDUFA goal date of October 25, 2024. If approved, oral sulopenem could become the first oral penem approved in the U.S., potentially offering a new treatment for multi-drug resistant pathogens in community settings.
Iterum Therapeutics (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing next-generation oral antibiotics, will participate in the 26th Annual H.C. Wainwright Global Investment Conference from September 9-11, 2024, in New York City. CEO Corey Fishman will present on September 10 at 8:30 AM ET and host investor meetings.
The conference, held at the Lotte New York Palace Hotel, is open to qualified investors. Iterum's management will be available for one-on-one meetings on September 10. A replay of the webcast presentation will be accessible on Iterum's website in the Events & Presentations section after the event.
Iterum Therapeutics (NASDAQ: ITRM) reported Q2 2024 financial results and provided updates on its oral sulopenem NDA for uUTI treatment. Key highlights:
- FDA PDUFA action date set for October 25, 2024
- Advisory Committee meeting scheduled for September 9, 2024
- Completed rights offering, raising $7.4 million gross proceeds
- Cash runway extended into 2025
- Q2 2024 R&D expenses decreased to $2.1 million from $9.0 million in Q2 2023
- Q2 2024 net loss reduced to $5.0 million from $12.2 million in Q2 2023
- Cash position of $11.7 million as of June 30, 2024
The company continues to work with the FDA during the NDA review process and is preparing for the upcoming Advisory Committee meeting.
FAQ
What is the current stock price of Iterum Therapeutics plc Ordinary Share (ITRM)?
What is the market cap of Iterum Therapeutics plc Ordinary Share (ITRM)?
What is Iterum Therapeutics plc?
What is sulopenem?
What recent achievements has Iterum Therapeutics made?
What is the REASSURE trial?
What designations has sulopenem received from the FDA?
When is the FDA's PDUFA action date for sulopenem?
What are Iterum Therapeutics' financial highlights?
What strategic options is Iterum Therapeutics exploring?
How does sulopenem address antibiotic resistance?
Where can I find more information about Iterum Therapeutics?
