Welcome to our dedicated page for Iterum Therapeutics Plc news (Ticker: ITRM), a resource for investors and traders seeking the latest updates and insights on Iterum Therapeutics Plc stock.
Iterum Therapeutics plc (Nasdaq: ITRM) is a pharmaceutical company focused on next generation oral and IV antibiotics designed to treat infections caused by multi-drug resistant pathogens in community and hospital settings. Its news flow centers on the development, approval and commercialization of sulopenem-based therapies, particularly the oral product ORLYNVAH™.
Company press releases highlight regulatory milestones, including U.S. Food and Drug Administration approval of ORLYNVAH™ (oral sulopenem) for adult women with uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis who have limited or no alternative oral antibacterial options. News items also cover the U.S. commercial launch of ORLYNVAH™ and its rollout into the community market through a commercialization partnership with EVERSANA Life Science Services, LLC.
Investors and observers following ITRM news will see updates on market access and reimbursement, such as contracts with group purchasing organizations working with major pharmacy benefit managers (PBMs), rebate agreements with Medicare Part D PBMs, and coverage developments across commercial, Medicare and government plans. Additional coverage includes specialty distribution arrangements with McKesson and Cencora, which enable physicians to obtain ORLYNVAH™ through preferred channels.
Iterum’s news stream also features patent estate developments in regions such as China, Mexico, Canada, Europe and Japan, as well as scientific presentations at conferences like IDWeek and publication of Phase 3 trial data in NEJM Evidence. Financial result announcements, at-the-market equity offering updates and Nasdaq listing compliance notices provide further context on the company’s capital markets activity.
For those tracking Iterum Therapeutics, the ITRM news page offers a consolidated view of clinical, regulatory, commercial, intellectual property and listing-related announcements that shape the company’s progress in the anti-infective space.
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) 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.
- Cash position of $12.7 million as of March 31, 2025 - Raised additional $5 million through a registered direct offering and $1 million via ATM program - Extended cash runway into 2026 - Q1 2025 net loss of $4.9 million, improved from $7.1 million in Q1 2024 - Research and development expenses decreased to $0.6 million from $4.0 million year-over-year
The company plans to launch ORLYNVAH™ either through a commercial partner or independently with a targeted sales force, focusing on addressing the growing antimicrobial resistance issue in uUTI treatment.Iterum Therapeutics (Nasdaq: ITRM), a pharmaceutical company specializing in next-generation oral and IV antibiotics for multi-drug resistant pathogens, has scheduled its first quarter 2025 financial results release for May 13, 2025, before U.S. markets open. 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 at 833-470-1428 (domestic) or 404-975-4839 (international) using Access Code 371859. A pre-registration link is available, and an audio webcast will be accessible in the Investors section of Iterum's website after the call.
Iterum Therapeutics has successfully closed a $5 million registered direct offering of ordinary shares, selling 5,555,556 shares at $0.90 per share to a single institutional investor. H.C. Wainwright & Co served as the exclusive placement agent for this transaction.
The company, which focuses on developing next-generation oral and IV antibiotics for multi-drug resistant pathogens, plans to use the net proceeds for working capital and general corporate purposes. Key potential uses include funding their ongoing strategic process and pre-commercialization activities for ORLYNVAH™, including product manufacturing, sales, marketing, and distribution.
The offering was conducted through a shelf registration statement on Form S-3 filed with the SEC. The transaction was completed on April 30, 2025, strengthening the company's financial position as they advance their antibiotic development programs.
Iterum Therapeutics (Nasdaq: ITRM) has secured a $5 million registered direct offering through the sale of 5,555,556 ordinary shares at $0.90 per share to a single institutional investor. The offering, expected to close around April 30, 2025, is being facilitated by H.C. Wainwright & Co as the exclusive placement agent.
The company, which specializes in developing next-generation oral and IV antibiotics for multi-drug resistant pathogens, plans to use the proceeds for:
- Working capital and general corporate operations
- Funding ongoing strategic process
- Pre-commercialization activities
- Manufacturing, sales, marketing, and distribution of ORLYNVAH™
The offering is made under a shelf registration statement filed with the SEC on October 7, 2022 (effective October 17, 2022). A prospectus supplement will be available on the SEC website.
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