DUBLIN and CHICAGO - Iterum Therapeutics plc (NASDAQ:ITRM) announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid). This medication is indicated for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women, specifically caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis. ORLYNVAH™ is the first oral penem antibiotic to be approved in the U.S. and represents a new option for patients with limited or no alternative oral antibacterial treatments.
The FDA's decision is based on the results from two pivotal Phase 3 clinical trials, which demonstrated the drug's safety and efficacy in comparison to ciprofloxacin and Augmentin™. In these studies, ORLYNVAH™ showed superiority to ciprofloxacin in fluoroquinolone-resistant infections and was non-inferior and statistically superior to Augmentin™ in the Augmentin™ susceptible population. The most common adverse reactions in patients treated with ORLYNVAH™ were diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
Iterum's CEO, Corey Fishman, expressed gratitude to all involved in the development process and highlighted the significance of this approval for patients with difficult-to-treat uUTIs. He also mentioned the company's intent to seek strategic transactions to maximize value for stakeholders. Dr. Marjorie Golden, an infectious disease expert at Yale New Haven Hospital, also noted the importance of ORLYNVAH™ as a treatment alternative in the community setting.
uUTIs are a prevalent issue, with up to 60% of women experiencing an infection in their lifetime. Approximately 40 million uUTI prescriptions are written annually in the U.S., with around 1% of these infections being caused by pathogens resistant to all commonly available oral antibiotics.
Iterum Therapeutics is focused on combating multi-drug resistant pathogens and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. The company will host a conference call on Monday to discuss the FDA approval.
This article is based on a press release statement from Iterum Therapeutics plc.
In other recent news, Iterum Therapeutics has been grappling with potential delisting from the Nasdaq Market due to an equity shortfall. The pharmaceutical company is planning to request a hearing with the Nasdaq Hearings Panel to present a strategy to regain compliance. Iterum Therapeutics also successfully completed a rights offering, generating $5.8 million in net proceeds to support the development of their primary drug candidate, sulopenem. The company reported a significant reduction in net loss compared to the previous year and an extended cash runway into 2025. Additionally, shareholders approved the board's authority to issue shares for cash without pre-emptive rights, providing a quick funding option if needed. The company's oral antibiotic, sulopenem etzadroxil/probenecid, was discussed at a U.S. Food and Drug Administration (FDA) advisory committee meeting for its potential in treating uncomplicated urinary tract infections in adult women. Amid these developments, H.C. Wainwright maintains a Buy rating on Iterum shares. These are recent developments in Iterum Therapeutics' pursuit to advance its drug candidate through the regulatory process.
InvestingPro Insights
Following the FDA approval of ORLYNVAH™, Iterum Therapeutics plc (NASDAQ:ITRM) presents an intriguing investment case. According to InvestingPro data, the company's market capitalization stands at $31.9 million, reflecting its current position as a small-cap pharmaceutical player.
Despite the positive news, it's crucial to note that Iterum faces financial challenges. An InvestingPro Tip indicates that the company is "quickly burning through cash," which could be a concern for potential investors. This aligns with the company's focus on seeking strategic transactions to maximize stakeholder value, as mentioned in the article.
Another InvestingPro Tip reveals that Iterum "suffers from weak gross profit margins." This metric is particularly relevant given the company's recent FDA approval, as it may impact the profitability of ORLYNVAH™ once it enters the market.
On a more positive note, Iterum has shown a "high return over the last year," with a 1-year price total return of 79.97%. This significant increase could be attributed to market anticipation of the FDA approval.
It's worth noting that InvestingPro offers 7 additional tips for Iterum Therapeutics, providing a more comprehensive analysis for interested investors. These insights can be valuable in assessing the company's future prospects in light of its recent regulatory success.
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