DUBLIN – Iterum Therapeutics plc (NASDAQ:), a clinical-stage pharmaceutical company, announced today the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral antibiotic sulopenem etzadroxil/probenecid, intended for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This resubmission marks a significant milestone for Iterum, potentially offering a new treatment option for the estimated 40 million uUTIs occurring annually in the U.S.
The resubmitted NDA includes data from the phase 3 clinical trials REASSURE, SURE 1, SURE 2, and SURE 3, which have collectively shown that oral sulopenem was well tolerated with no identified safety issues. The REASSURE trial demonstrated that oral sulopenem was non-inferior to Augmentin® for the primary efficacy endpoint, with a statistically significant superiority in overall success rate. The SURE 1 trial indicated statistical superiority of oral sulopenem over ciprofloxacin for patients with a quinolone non-susceptible pathogen.
Iterum’s CEO, Corey Fishman, expressed optimism about the resubmission, highlighting the potential benefits of penem antibiotics in oral form, which have previously been available only via IV formulations in the U.S. The company anticipates that if the FDA’s review process confirms the NDA addresses the deficiencies noted in the Complete Response Letter received in July 2021, a decision could be made by early Q4 2024.
Iterum Therapeutics focuses on developing antibiotics to combat multi-drug resistant pathogens. Sulopenem, their lead compound, has shown potent activity against a broad range of bacteria and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations in seven indications.
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The information in this article is based on a press release statement from Iterum Therapeutics plc.
InvestingPro Insights
As Iterum Therapeutics plc (NASDAQ:ITRM) advances with the resubmission of its New Drug Application (NDA) for its oral antibiotic, potential investors and stakeholders are closely monitoring the company’s financial health and stock performance. According to real-time data from InvestingPro, Iterum has a market capitalization of $27.65 million USD, illustrating its position as a smaller player in the pharmaceutical industry.
InvestingPro Tips indicate that Iterum holds more cash than debt on its balance sheet, which could provide some financial flexibility as the company moves forward with the FDA review process. However, analysts are not optimistic about the company’s profitability in the near term, as Iterum is not expected to be profitable this year and has not been profitable over the last twelve months.
In terms of stock performance, Iterum’s shares have experienced a large price uptick over the last six months, with a 149.25% return. This volatility is a critical factor for investors to consider, as reflected in the 67.6% price percentage of the 52-week high. Despite the recent gains, the company’s stock price is still below the InvestingPro Fair Value estimate of $1.62 USD.
For those interested in a deeper analysis, there are additional InvestingPro Tips available, which can be accessed through the dedicated page for Iterum Therapeutics: https://www.investing.com/pro/ITRM. To get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, use the coupon code PRONEWS24.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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