Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics plc (Nasdaq: ITRM) announced that it will release its third quarter 2022 financial results on November 10, 2022, before U.S. market opening. A conference call will follow at 8:30 a.m. ET for discussing these results and business updates. The Company is progressing its lead product, sulopenem, a novel anti-infective in Phase 3 clinical development, demonstrating effectiveness against multi-drug resistant pathogens. Iterum has secured QIDP and Fast Track designations for sulopenem across seven indications.

Iterum Therapeutics announced the dosing of the first patient in its Phase 3 clinical trial, REASSURE, for oral sulopenem aimed at treating uncomplicated urinary tract infections (uUTI) caused by resistant pathogens. This trial compares oral sulopenem to Augmentin and is being conducted under an FDA Special Protocol Assessment. Successful completion of the trial could lead to a resubmission of the new drug application (NDA) in late 2024. The trial is expected to enroll approximately 1,966 patients.

Iterum Therapeutics plc (Nasdaq: ITRM) announced the presentation of two posters at IDWeek 2022, addressing critical advancements in tackling multi-drug resistant infections. The studies include data on the impact of asymptomatic bacteriuria in UTI treatment, and the efficacy of sulopenem against Bacillus anthracis. The conference runs from October 19-23 in Washington, D.C., with poster presentations scheduled for October 20 and 22. These findings will eventually be accessible on the company's website, emphasizing Iterum's commitment to developing novel antibiotics.

Iterum Therapeutics (Nasdaq: ITRM) received a Notice of Allowance from the U.S. Patent Office for patent application number 16/972,300, enhancing protection for its lead candidate, oral sulopenem. This patent extends protection until at least 2039, crucial for its commercial potential. Oral sulopenem aims to be the first oral penem in the U.S. and the first new treatment for uncomplicated urinary tract infections in over two decades. The company is preparing for a pivotal Phase 3 clinical trial expected to begin soon.

Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company, announced its participation in the H.C. Wainwright 24th Annual Hybrid Global Investment Conference on September 14, 2022, at 12:00 PM (ET). CEO Corey Fishman and CFO Judy Matthews will present a company overview and business update. Investor meetings are scheduled for September 13-14, 2022. The presentation will be accessible for 90 days on the company's website under the 'Investors' section. Iterum focuses on developing innovative antibiotics like sulopenem, which is in Phase 3 clinical development.

Iterum Therapeutics (Nasdaq: ITRM) announced it has regained compliance with Nasdaq's minimum bid price requirement after its shares maintained a closing bid price of over $1.00 for ten consecutive trading days, as of August 31, 2022. Previously, the company faced non-compliance issues that began in September 2021, receiving extensions to meet the requirement. Now, Iterum is in compliance with all listing standards and will continue to trade on the Nasdaq Capital Market.

Iterum Therapeutics plc (Nasdaq: ITRM) announced a 1-for-15 reverse share split effective at 5:00 p.m. ET on August 17, 2022, with trading to commence on August 18. This move follows shareholder approval at the AGM on June 15, 2022, to comply with Nasdaq's minimum $1.00 per share requirement. Post-split, outstanding shares will decrease from approximately 183.3 million to about 12.2 million. The nominal value of shares will adjust from $0.01 to $0.15. The reverse split also affects other equity instruments and does not create fractional shares, offering cash payments instead.

Iterum Therapeutics (ITRM) announced a planned Phase 3 clinical trial for oral sulopenem targeting uncomplicated urinary tract infections (uUTI), set to begin enrollment in Q4 2022. The company secured a Special Protocol Assessment (SPA) agreement with the FDA, which validates the trial design. Financially, Iterum reported a cash position of $68.9 million as of June 30, 2022, sufficient to fund operations into 2024. However, the net loss increased to $6.7 million for Q2 2022, contrasting with a net income of $7.8 million in Q2 2021.

Iterum Therapeutics announced an agreement with the FDA under the Special Protocol Assessment (SPA) for a Phase 3 clinical trial of oral sulopenem in treating uncomplicated urinary tract infections (uUTI). The SPA confirms the trial's design, endpoints, and statistical analysis are sufficient for a potential resubmission of the new drug application (NDA). The study aims to enroll about 1,966 patients and will compare oral sulopenem to Augmentin, with recruitment expected to start in Q4 2022.