Iterum Therapeutics Plc - ITRM STOCK NEWS

Iterum Therapeutics (Nasdaq: ITRM), a developer of next-generation oral and IV antibiotics targeting multi-drug resistant pathogens, has scheduled its fourth quarter and full year 2024 financial results release for February 7, 2025, before U.S. markets open. The company will host a conference call at 8:30 a.m. ET on the same day, where management will discuss financial results and provide a business update. Investors can access the call via phone (833-470-1428 domestic, 404-975-4839 international) using Access Code 719739, with pre-registration available. An audio webcast will be accessible in the Investors section of the company's website after the call.

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.