Iterum Therapeutics Plc Stock Price, News & Analysis

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.

Iterum Therapeutics announced two data presentations at the IDSA IDWeek™ 2020 from October 21-25, covering results from the SURE-1 and SURE-2 trials for urinary tract infections. The SURE-1 trial demonstrated that oral sulopenem was statistically superior to oral ciprofloxacin in treating uncomplicated urinary tract infections (uUTI). Results from both trials will be presented by Michael Dunne, showing the comparative efficacy and safety of sulopenem against existing treatments for complicated and uncomplicated infections.

Iterum Therapeutics announced two upcoming data presentations at the IDWeek™ 2020, set for October 21-25, 2020. This includes findings from the SURE-1 trial demonstrating oral sulopenem's effectiveness against uncomplicated urinary tract infections (uUTI) compared to oral ciprofloxacin, deemed statistically superior. Additionally, results from the SURE-2 trial on complicated urinary tract infections (cUTI) will be shared. The company is progressing with sulopenem as a novel anti-infective aimed at combating antibiotic resistance.

Iterum Therapeutics has announced plans to submit a New Drug Application (NDA) for sulopenem etzadroxil/probenecid, a treatment for uncomplicated urinary tract infections caused by quinolone-resistant pathogens. Following a positive pre-NDA meeting with the FDA, the company has received confidence regarding the submission's requirements. Over 6 million quinolone-resistant urinary tract infections occur annually in the U.S., and sulopenem has shown effectiveness exceeding ciprofloxacin. The company has been granted Fast Track and Qualified Infectious Disease Product designations for sulopenem.

Iterum Therapeutics (Nasdaq: ITRM) plans to submit a New Drug Application (NDA) for sulopenem etzadroxil/probenecid, aimed at treating uncomplicated urinary tract infections caused by quinolone-resistant pathogens. Following a pre-NDA meeting with the FDA, Iterum is confident about its submission strategy. Each year, over 6 million quinolone-resistant UTIs occur in the U.S. The NDA follows sulopenem's proven superiority over ciprofloxacin in clinical settings. The company’s innovative approach addresses the growing crisis of multi-drug resistant infections.

Iterum Therapeutics announced its participation in the 22^nd Annual H.C. Wainwright Global Investment Conference, taking place virtually from September 14 – 16, 2020. CEO Corey Fishman will present an overview of the company on September 16, 2020, at 10:00 a.m. ET. The company is dedicated to developing antibiotics to combat multi-drug resistant pathogens, focusing on its lead compound, sulopenem, currently in Phase 3 clinical development. Iterum has received QIDP and Fast Track designations for sulopenem in seven indications.