DUBLIN and CHICAGO - Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company, announced Monday that its new drug application (NDA) for the oral antibiotic sulopenem etzadroxil/probenecid was the subject of a recent U.S. Food and Drug Administration (FDA) advisory committee meeting. The Antimicrobial Drugs Advisory Committee (AMDAC) convened on September 9 to discuss the treatment of uncomplicated urinary tract infections (uUTI) in adult women with the drug.
At the meeting, the FDA sought input on the benefits and risks associated with the use of sulopenem etzadroxil/probenecid, which has the potential to be the first oral penem antibiotic approved in the United States. The committee also considered information important for medical providers to ensure the appropriate use of the drug, which is critical in limiting antimicrobial resistance.
Iterum's Chief Executive Officer, Corey Fishman, expressed encouragement by the AMDAC's acknowledgment of oral sulopenem as an important treatment option for patients with uUTI. The company looks forward to continuing discussions with the FDA on the review and potential labeling of the drug in the coming months.
The AMDAC was presented with scientific evidence from Iterum, including data from the pivotal REASSURE Phase 3 clinical trial and the SURE-1 Phase 3 clinical trial. While the FDA is not obligated to follow the recommendations of the AMDAC, it typically takes the committee's advice into account.
The FDA's decision on the approval of oral sulopenem for the treatment of uUTIs in adult women is anticipated by the Prescription Drug User Fee Act (PDUFA) goal date of October 25, 2024. This comes in the context of the increasing challenge of treating UTIs due to the development of resistance by pathogens responsible for these infections, with a significant percentage of infections caused by organisms resistant to existing oral antibiotics.
Iterum Therapeutics is dedicated to developing anti-infectives to combat multi-drug resistant pathogens. The company's submission of an NDA for oral sulopenem has been accepted for review by the FDA and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations in seven indications.
This news article is based on a press release statement from Iterum Therapeutics.
In other recent news, Iterum Therapeutics has announced significant developments in its financial and strategic operations. The pharmaceutical company successfully completed a rights offering, generating $5.8 million in net proceeds. These funds are set to support the strategic process to maximize the value of sulopenem, the company's key drug candidate.
Iterum Therapeutics also has significant milestones on the horizon, including an upcoming meeting with the FDA's Antimicrobial Drugs Advisory Committee to discuss the resubmitted new drug application for oral sulopenem. The company expects the FDA's decision by October 25, 2024.
Financially, the company has reported a significant reduction in net loss compared to the previous year and an extended cash runway into 2025. Iterum Therapeutics has also expanded its intellectual property estate with new patents in the US and Canada.
Finally, the company is seeking shareholder approval to raise additional capital through share issuances. These recent developments reflect Iterum Therapeutics' commitment to advancing its drug candidate through the regulatory process.
InvestingPro Insights
As Iterum Therapeutics plc (NASDAQ:ITRM) awaits the FDA's decision on its new drug application, the company's financial health and market performance provide a broader context for stakeholders. With a market capitalization of 24.52 million USD, Iterum presents as a small-cap biopharmaceutical firm in the competitive drug development landscape. The company's recent financial metrics reveal significant challenges, with an adjusted operating income of -38.26 million USD over the last twelve months as of Q2 2024, reflecting the high costs associated with clinical trials and research and development.
InvestingPro data indicates that Iterum Therapeutics has not been profitable over the past year, and analysts do not expect it to be profitable this year either. This is underscored by a negative price-to-earnings (P/E) ratio of -0.55, which further adjusted to -0.87 in the last twelve months. The company's stock price has also been subject to volatility, with a 1-month price total return showing a decrease of -8.47%. These financial challenges are further compounded by the InvestingPro Tip that the company is quickly burning through cash, with short-term obligations exceeding its liquid assets.
Despite these financial headwinds, Iterum Therapeutics has managed to capture the attention of the market, with its stock price currently at 43.2% of its 52-week high and an average daily volume over the past three months of 0.28 million USD. This level of activity may reflect investor interest tied to the potential FDA approval and the company's strategic focus on addressing antimicrobial resistance.
For those considering an investment in Iterum Therapeutics, additional InvestingPro Tips that might be of interest include the high shareholder yield and the company's lack of dividend payments to shareholders. It's worth noting that there are many more tips available on InvestingPro's platform, providing deeper insights into Iterum's financial health and market prospects.
Investors and stakeholders can find a total of 9 InvestingPro Tips on Iterum Therapeutics, which offer a comprehensive view of the company's financial situation and market potential. These tips can be accessed by visiting the InvestingPro platform for Iterum Therapeutics at https://www.investing.com/pro/ITRM.
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