DUBLIN and CHICAGO - Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) action date of October 25, 2024, for the review of its oral sulopenem antibiotic. The drug is intended to treat uncomplicated urinary tract infections (uUTIs) in adult women.
The FDA's acceptance of the New Drug Application (NDA) resubmission marks a significant step for Iterum, as it moves closer to potentially bringing oral sulopenem to the market. The resubmission includes data from the REASSURE clinical trial, which showed that oral sulopenem was non-inferior to the comparator drug Augmentin® in treating uUTIs caused by resistant Enterobacterales.
The REASSURE trial, conducted under an FDA Special Protocol Assessment agreement, demonstrated that oral sulopenem achieved a statistically significant superiority in overall success rate compared to Augmentin® for patients with an Augmentin® susceptible pathogen. This finding was based on the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit.
Iterum's CEO, Corey Fishman, expressed optimism about the FDA's acceptance of the NDA resubmission, highlighting the potential of oral sulopenem to address the needs of patients and physicians in an underserved market.
Oral sulopenem, a novel penem anti-infective compound, has shown potent in vitro activity against a broad range of resistant bacteria. The compound has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for both its oral and intravenous (IV) formulations across seven indications.
Iterum Therapeutics is committed to combating the global crisis of multi-drug-resistant pathogens and improving the lives of those affected by serious diseases. The company's focus remains on advancing sulopenem through clinical development to meet the urgent need for new antibiotics.
This announcement is based on a press release statement from Iterum Therapeutics plc.
InvestingPro Insights
As Iterum Therapeutics plc (NASDAQ:ITRM) gears up for the FDA's review of its oral sulopenem antibiotic, investors are closely watching the company's financial health and market performance. Here are some key metrics and insights from InvestingPro to consider:
InvestingPro Data highlights that Iterum Therapeutics has a market capitalization of 21.36 million USD. The company's performance over the last month shows a price total return of -15.69%, reflecting recent market challenges. Additionally, the stock is currently trading at 51.6% of its 52-week high, with a previous close at 1.29 USD.
From an operational standpoint, the company's adjusted operating income for the last twelve months as of Q1 2024 stands at -45.1 million USD, which underscores the financial hurdles Iterum faces as it seeks FDA approval for its key drug candidate.
InvestingPro Tips indicate that Iterum is rapidly depleting its cash reserves and suffers from weak gross profit margins. Moreover, analysts do not expect the company to be profitable this year. These factors are critical for investors to consider as they evaluate the company's long-term viability and the potential impact of the FDA's decision on the stock's value.
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