ORLYNVAH™

Search documents
Iterum Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-07-02 20:30
Company Overview - Iterum Therapeutics plc is focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][3] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [3] Recent Developments - Iterum has granted a non-statutory share option to purchase 200,000 ordinary shares to Christine Coyne, the newly appointed Chief Commercial Officer [1][2] - The share option has an exercise price of $0.97 per share, equal to the closing price on the date of grant, and vests over four years [2] Product Information - ORLYNVAH™ is a novel oral penem antibiotic developed by Iterum for the treatment of uncomplicated urinary tract infections (uUTIs) [3][4] - ORLYNVAH™ is effective against Enterobacterales species that are resistant to third-generation cephalosporins due to extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases [4]
Iterum Names Christine Coyne as Chief Commercial Officer to Lead ORLYNVAH™ Launch and Commercial Growth
Globenewswire· 2025-06-30 11:00
Company Overview - Iterum Therapeutics plc is focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][4] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [4] Leadership Appointment - Christine Coyne has been appointed as the Chief Commercial Officer, a newly created position, to lead all commercial efforts for Iterum [1][2] - Coyne brings over 30 years of experience in the pharmaceutical industry, with a strong background in anti-infectives [2][3] Product Launch - The upcoming launch of ORLYNVAH™, an oral formulation of sulopenem, is a significant opportunity for the company to address unmet medical needs in treating uncomplicated urinary tract infections (uUTIs) [1][3][5] - ORLYNVAH™ has received FDA approval for the treatment of uUTIs caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options [4][5] Market Positioning - The company aims to accelerate launch readiness for ORLYNVAH™ and scale its capabilities for long-term growth [2][3] - ORLYNVAH™ is designed to be effective against Enterobacterales species that are resistant to third-generation cephalosporins [5]
Iterum Therapeutics Announces Publication of REASSURE Trial in NEJM Evidence
Globenewswire· 2025-06-25 11:00
DUBLIN and CHICAGO, June 25, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the "Company" or "Iterum"), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that NEJM Evidence published results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadrox ...
Iterum Therapeutics Announces Partnership for Commercialization Services
Globenewswire· 2025-06-11 11:00
U.S. Commercial Launch of ORLYNVAHTM by Q4 2025; First Oral Penem Available in the U.S. Management to host a conference call at 4:30 p.m. ET today DUBLIN and CHICAGO, June 11, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that it entered into a Product Commercialization Agree ...
Iterum Therapeutics Announces Closing of $5 Million Registered Direct Offering of Ordinary Shares
Globenewswire· 2025-04-30 20:30
Core Viewpoint - Iterum Therapeutics plc has successfully completed a registered direct offering of 5,555,556 ordinary shares at a price of $0.90 per share, raising approximately $5 million in gross proceeds to support its operations and strategic initiatives [1][3]. Group 1: Offering Details - The offering was conducted with a single institutional investor and facilitated by H.C. Wainwright & Co. as the exclusive placement agent [2][3]. - The net proceeds from the offering are intended for working capital and general corporate purposes, including funding ongoing strategic processes and pre-commercialization activities [3]. Group 2: Company Overview - Iterum Therapeutics focuses on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens, with its lead compound being sulopenem [6]. - Sulopenem has shown potent in vitro activity against various resistant bacteria and has received FDA approval for its oral formulation, ORLYNVAH™, for treating uncomplicated urinary tract infections in adult women [6].
Iterum Therapeutics Announces $5 Million Registered Direct Offering of Ordinary Shares
Globenewswire· 2025-04-29 12:00
Core Viewpoint - Iterum Therapeutics plc has entered into a definitive agreement for a registered direct offering of 5,555,556 ordinary shares at a price of $0.90 per share, expected to close around April 30, 2025 [1][3] Group 1: Offering Details - The gross proceeds from the offering are anticipated to be approximately $5 million before deducting fees and expenses [3] - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The offering is conducted under a shelf registration statement filed with the SEC, effective since October 17, 2022 [4] Group 2: Use of Proceeds - The net proceeds will be used for working capital and general corporate purposes, including ongoing strategic processes and pre-commercialization activities [3] - Specific uses for the proceeds have not been identified, but they may fund expenses related to the commercialization of ORLYNVAH™, including manufacturing, sales, and marketing [3][6] Group 3: Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens [6] - The company is advancing its first compound, sulopenem, which has shown potent activity against various resistant bacteria [6] - ORLYNVAH™ has received FDA approval for treating uncomplicated urinary tract infections in women with limited treatment options [6]