Iterum Therapeutics Plc Stock Price, News & Analysis

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.

Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing next-generation oral and IV antibiotics, has announced its plans to release second quarter 2024 financial results on August 14, 2024, before the U.S. financial markets open. The company will host a conference call at 8:30 a.m. ET on the same day to discuss the results and provide a business update.

Investors and interested parties can access the call by dialing 833-470-1428 (domestic) or 404-975-4839 (international) and using the Access Code 775539. A pre-registration option is available. The audio webcast will be accessible under the "Financials & Filings" section of Iterum's website at www.iterumtx.com following the call.

Iterum Therapeutics plc (Nasdaq: ITRM) announced the expiration and results of its rights offering on August 6, 2024. The company distributed 17,007,601 non-transferable subscription rights to purchase 8,503,800 units at $1.21 per unit. Each unit consisted of one ordinary share and warrants. 6,121,965 units were validly subscribed for during the offering, with an additional 5,091,550 units exercised through over-subscription privileges. Iterum expects to receive gross proceeds of approximately $7.4 million, with estimated expenses of $1.1 million. The company plans to deliver the ordinary shares and warrants to rights holders and the warrant agent, respectively, on or about August 9, 2024.