Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics (Nasdaq: ITRM) has commenced its previously announced rights offering. The company is distributing non-transferable subscription rights to eligible shareholders and warrant holders to purchase up to 8,503,800 units at $1.21 per unit. Each unit consists of one ordinary share, a 1-year warrant, and a 5-year warrant. The subscription period runs from July 22 to August 6, 2024. If fully subscribed, the offering could result in the issuance of 8,503,800 ordinary shares and warrants to purchase up to 12,755,700 additional shares. The company has engaged Maxim Group as the dealer-manager for the offering.

Iterum Therapeutics announced that the FDA has scheduled an Advisory Committee meeting on September 9, 2024, to discuss the NDA for oral sulopenem for treating uncomplicated urinary tract infections (uUTIs) in adult women. The discussion will address antimicrobial stewardship and the target patient population for this first-of-its-kind oral penem in the U.S. In April 2024, Iterum resubmitted the NDA, which the FDA accepted in May 2024, classifying it as a Class II complete response with a review period of six months. The FDA has set a PDUFA action date of October 25, 2024.

Iterum Therapeutics (Nasdaq: ITRM) has announced its participation in the ASM Microbe 2024 conference in Atlanta, Georgia, from June 13-17, 2024. The company will present a poster titled 'In Vitro Assessment of Sulopenem against Mycobacterium avium Complex' on June 16, 2024, from 10:00 a.m. to 4:00 p.m. in the Exhibit Hall. The presentation falls under the category of 'New Antimicrobial Agents' and will be delivered by Dr. Steven I. Aronin. The poster will be available on Iterum Therapeutics' website after the conference.

Iterum Therapeutics announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) in adult women. The FDA has assigned a PDUFA action date of October 25, 2024. This milestone follows the REASSURE clinical trial, which showed that oral sulopenem was non-inferior to Augmentin® and even demonstrated statistically significant superiority in overall success rate. The FDA's acceptance marks a critical step towards potentially providing a new treatment option for uUTIs, addressing a significant unmet medical need.

Iterum Therapeutics reported its first quarter 2024 financial results, highlighting the resubmission of its NDA for oral sulopenem. The company expects FDA action in early Q4 2024. With cash runway into 2025, Iterum sold 3 million shares for net proceeds of $7.2 million. The company's current cash position is expected to fund operations through 2025.

Iterum Therapeutics plc (Nasdaq: ITRM) will report its first quarter 2024 financial results on May 13, 2024. The company focuses on developing oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens. A conference call will be held to discuss financial results and business updates.

Iterum Therapeutics has resubmitted its New Drug Application for oral sulopenem to the U.S. FDA for the treatment of uncomplicated urinary tract infections. The potential approval of oral sulopenem, the first oral penem in the U.S. and the second new oral treatment for uUTIs in over 25 years, could benefit an estimated 40 million women suffering from uUTIs annually in the U.S. The NDA resubmission includes data from phase 3 clinical trials showing oral sulopenem's efficacy and safety, positioning it as a promising new antibiotic option.