Welcome to our dedicated page for Iterum Therapeutics plc Ordinary Share news (Ticker: ITRM), a resource for investors and traders seeking the latest updates and insights on Iterum Therapeutics plc Ordinary Share stock.
Iterum Therapeutics plc (Nasdaq: ITRM) is an Ireland-based clinical-stage pharmaceutical company committed to developing unique anti-infectives to address the global crisis of multi-drug resistant (MDR) pathogens. The company's flagship product, sulopenem, is a novel penem anti-infective available in both oral and intravenous formulations. Sulopenem has shown potent in-vitro activity against a wide range of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics.
Currently, Iterum is focused on advancing sulopenem through Phase 3 clinical development. The company recently completed its REASSURE trial—a critical study comparing oral sulopenem to oral Augmentin® in adult women with uncomplicated urinary tract infections (uUTIs). The trial demonstrated that oral sulopenem was non-inferior to Augmentin® for the primary efficacy endpoint, with statistically significant superiority in overall success rates.
Iterum has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for sulopenem in seven indications from the U.S. Food and Drug Administration (FDA). The company recently resubmitted its New Drug Application (NDA) for oral sulopenem, which has been accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) action date set for October 25, 2024.
Financially, Iterum reported robust research and development (R&D) expenditures, primarily driven by the REASSURE trial. The company’s net loss decreased in 2023 compared to the previous year, reflecting its focused investment in key clinical trials and strategic projects.
Iterum is actively seeking partnerships and strategic options to maximize the value of sulopenem, including potential sales or licensing agreements. The firm's dedicated efforts in combating MDR pathogens aim to significantly improve the lives of people affected by serious and life-threatening diseases.
Iterum Therapeutics plc (Nasdaq: ITRM) announced an underwriting agreement with H.C. Wainwright & Co. to sell 8,695,653 ordinary shares at $1.15 each, potentially raising approximately $10 million. An additional 1,304,347 shares may be purchased by the underwriter. Proceeds will primarily support the review of its New Drug Application for oral sulopenem, pre-commercialization activities, and working capital. The offering is expected to close around February 8, 2021. The company anticipates sufficient funds to support operations into Q1 2022, but warns of inherent risks to projections.
Iterum Therapeutics (Nasdaq: ITRM) announced a partnership with EVERSANA™ to initiate pre-launch activities for its oral sulopenem, targeting uncomplicated urinary tract infections (uUTIs). The FDA accepted the New Drug Application (NDA) for sulopenem, with a priority review and a PDUFA date set for July 25, 2021. The collaboration aims to enhance market access, strategic marketing, and medical education, preparing for a potential late 2021 launch. The CEO expressed confidence in EVERSANA's capabilities to support an effective launch of this antibiotic aimed at combating multi-drug resistant pathogens.
Iterum Therapeutics announced that the FDA accepted its New Drug Application for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs). This application has been designated for priority review, with a PDUFA goal date of July 25, 2021. If approved, sulopenem would be the first oral penem in the U.S. and the first new treatment for uUTIs in over 20 years, addressing the issue of quinolone resistance in millions of U.S. cases annually. The NDA includes positive data from Phase 3 clinical trials demonstrating superior efficacy compared to ciprofloxacin.
Dublin-based Iterum Therapeutics plc (Nasdaq: ITRM) is set to participate in the virtual H.C. Wainwright BioConnect Conference from January 11-14, 2021. CEO Corey Fishman will present a company overview and business update, available on-demand starting January 11 at 6:00 a.m. Eastern Time. Iterum focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens. Their leading compound, sulopenem, is in Phase 3 clinical development and has received Fast Track and QIDP designations for its oral and IV formulations in seven indications.
On December 21, 2020, Iterum Therapeutics announced the resignation of Chief Scientific Officer Dr. Michael Dunne, who will continue as a strategic advisor and board member. Dr. Steve Aronin, Senior Vice President and Head of Clinical Development, will assume leadership of development and regulatory activities. The company submitted its New Drug Application (NDA) for oral sulopenem to the FDA in November 2020, aiming for a decision in Q3 2021. Iterum is focused on combating multi-drug resistant infections.
Iterum Therapeutics has announced its transfer from the Nasdaq Global Market to the Nasdaq Capital Market, effective December 23, 2020. This decision follows the company's compliance issues regarding the Bid Price Rule, as it has until March 23, 2021, to maintain a closing share price of $1.00 for 10 consecutive days. However, the company has regained compliance with the MVPHS Rule, meeting the market value requirement. The company is focused on developing antibiotics to treat infections caused by multi-drug resistant pathogens and is currently advancing its lead compound, sulopenem, in Phase 3 clinical development.
Iterum Therapeutics announced the filing of a U.S. patent application for a bilayer tablet formulation of sulopenem etzadroxil and probenecid, which if approved, could grant patent coverage until 2039. The application aims to enhance the commercial viability of their product targeting multi-drug resistant infections. The company received positive feedback from the International Search Authority, indicating novelty in several claims. They plan to pursue additional patents internationally, supporting potential partnerships.
Iterum Therapeutics has submitted a New Drug Application (NDA) to the FDA for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) caused by quinolone non-susceptible pathogens. This submission is pivotal, as it could introduce the first oral penem antibiotic in the U.S. in over two decades. The NDA includes successful data from three phase 3 clinical trials, showing oral sulopenem's superiority over ciprofloxacin. If approved, it could address the needs of over 6 million patients annually suffering from cipro-resistant UTIs.
Iterum Therapeutics (Nasdaq: ITRM) reported its Q3 2020 financial results, highlighting the imminent NDA filing for oral sulopenem to treat uncomplicated urinary tract infections (uUTIs). The company received positive FDA feedback at their September pre-NDA meeting and anticipates market introduction of this novel therapy within the next three quarters. They raised $17.4 million in October, extending their cash runway into Q3 2021. Q3 net loss decreased to $12.2 million, down from $31.3 million in 2019, while R&D expenses significantly fell to $3.9 million from $28.1 million year-over-year.
Iterum Therapeutics (Nasdaq: ITRM) announced a public offering of 26,923,076 ordinary shares at $0.65 per share, alongside warrants for 20,192,307 shares. The offering, expected to close on October 27, 2020, aims to raise approximately $17.5 million for its clinical initiatives, including the New Drug Application for oral sulopenem targeting urinary tract infections linked to quinolone-resistant pathogens. H.C. Wainwright & Co. acts as the exclusive placement agent. The offering is registered under Form S-1 with the SEC, effective October 22, 2020.
FAQ
What is the current stock price of Iterum Therapeutics plc Ordinary Share (ITRM)?
What is the market cap of Iterum Therapeutics plc Ordinary Share (ITRM)?
What is Iterum Therapeutics plc?
What is sulopenem?
What recent achievements has Iterum Therapeutics made?
What is the REASSURE trial?
What designations has sulopenem received from the FDA?
When is the FDA's PDUFA action date for sulopenem?
What are Iterum Therapeutics' financial highlights?
What strategic options is Iterum Therapeutics exploring?
How does sulopenem address antibiotic resistance?
Where can I find more information about Iterum Therapeutics?
