Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics (Nasdaq: ITRM), a developer of next-generation antibiotics, provided key business updates on its recently launched drug ORLYNVAH™. The drug was launched in August 2025 across seven U.S. states in partnership with EVERSANA Life Science Services. The company is actively working on expanding market access through discussions with major pharmacy benefit managers.

Key developments include FDA 510(k) clearance for its Antimicrobial Susceptibility Test Disc, new patent grants in China and Mexico, and sufficient cash runway into 2026, supported by $2.2 million raised through its at-the-market offering program. The company will present at IDWeek 2025 in Atlanta on October 21, focusing on urinary tract infections and oral sulopenem.

Iterum Therapeutics (Nasdaq: ITRM) has launched ORLYNVAH™ (sulopenem etzadroxil and probenecid), marking a significant milestone as the first oral penem antibiotic available in the U.S. The FDA-approved treatment targets uncomplicated urinary tract infections (uUTIs) in adult women, specifically those caused by specific bacteria with limited treatment alternatives.

The launch addresses a critical medical need, as 57% of initial UTI infections show resistance to at least one antibiotic class, and 13% are resistant to three or more antibiotics. ORLYNVAH™ represents the first new branded product for uUTI treatment in over 25 years. To enhance accessibility, Iterum is offering a copay savings program allowing eligible patients to obtain ORLYNVAH™ for as little as $25.

Iterum Therapeutics (Nasdaq: ITRM) reported Q2 2025 financial results and announced the upcoming launch of ORLYNVAH™, the first branded antibiotic for uncomplicated urinary tract infections (uUTIs) in over 25 years. The company reported a net loss of $6.5 million for Q2 2025, compared to $5.0 million in Q2 2024.

Key developments include a partnership with EVERSANA for U.S. commercialization, a manufacturing agreement with ACS Dobfar S.p.A, and the appointment of Christine Coyne as Chief Commercial Officer. The company's cash position of $13.0 million, plus $2.2 million raised through ATM offering, is expected to fund operations into 2026.

ORLYNVAH™, the only FDA-approved oral penem antibiotic in the U.S., targets resistant Gram-negative bacteria, including ESBL-producing Enterobacterales. The company also secured patent protection in Canada until 2039 and had its REASSURE Phase 3 trial results published in NEJM Evidence.

Iterum Therapeutics (Nasdaq: ITRM), a developer of next-generation oral and IV antibiotics, has scheduled its second quarter 2025 financial results announcement for August 5, 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 using the numbers 833-470-1428 (domestic) or 404-975-4839 (international) with Access Code 740801. A webcast will be available on the company's investor relations website.

Iterum Therapeutics (Nasdaq: ITRM), a company focused on developing next-generation antibiotics, has granted a non-statutory share option to its new Chief Commercial Officer, Christine Coyne. The option allows for the purchase of 200,000 ordinary shares at an exercise price of $0.97 per share.

The share option, granted on July 1, 2025, has a 10-year term and follows a four-year vesting schedule: 25% vests after the first year, with the remainder vesting monthly over 36 months. This grant was made as an inducement award under Nasdaq Listing Rule 5635(c)(4) and is part of Ms. Coyne's employment compensation package.

Iterum Therapeutics (Nasdaq: ITRM) has appointed Christine Coyne as Chief Commercial Officer to lead the upcoming U.S. launch of ORLYNVAH™ and future commercialization activities. Coyne brings over 30 years of pharmaceutical industry experience, most recently serving as Chief Commercial Officer at Innoviva.

In her previous roles, Coyne led commercial strategies at several pharmaceutical companies including SCYNEXIS, Paratek Pharmaceuticals, BTG Pharmaceuticals, Auxilium, Endo, and Wyeth/Pfizer. Her expertise in anti-infectives and track record of building commercial infrastructure will be crucial for Iterum's growth plans in addressing infections caused by multi-drug resistant pathogens.

Iterum Therapeutics (NASDAQ:ITRM) announced the publication of its REASSURE Phase 3 clinical trial results in NEJM Evidence. The trial compared oral sulopenem (combined with probenecid) to oral Augmentin for treating uncomplicated urinary tract infections (uUTIs) in adult women.

A significant finding revealed that 9.2% of patients in the trial's primary population had pathogens resistant to three or more antibiotic classes. The company's product, ORLYNVAH™, is expected to launch next quarter to address these hard-to-treat infections.

Iterum Therapeutics (NASDAQ: ITRM) has partnered with EVERSANA Life Science Services for the U.S. commercialization of ORLYNVAH, the first oral penem antibiotic to be available in the United States. The Product Commercialization Agreement outlines EVERSANA's role in providing comprehensive services including sales, marketing, logistics, channel management, regulatory, and medical affairs for ORLYNVAH's commercialization. The drug, targeting hard-to-treat uncomplicated urinary tract infections (uUTI) in community settings, is scheduled for U.S. market launch by Q4 2025. EVERSANA's integrated commercialization platform will be leveraged to ensure rapid and efficient market access for patients with limited or no oral treatment options.

Iterum Therapeutics (NASDAQ: ITRM) announced that Pfizer has agreed to extend the payment deadline for a $20.0 million regulatory milestone payment from October 2026 to October 25, 2029. The milestone payment is associated with the FDA approval of ORLYNVAH™, which was received on October 25, 2024. Under the amended terms, the annual interest rate will increase from 8% to 10% (compounded daily) starting October 26, 2026.

The extension allows Iterum to strategically invest capital raised or earned from ORLYNVAH™ sales into expanding into new territories and focusing on high-prescribing geographies. The amended agreement includes restrictions on ITIL's ability to incur senior debt or create liens on its assets without Pfizer's consent.