Iterum Therapeutics Secures 510(k) Approval for Susceptibility Test Disc
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
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Business Update from Iterum Therapeutics: Iterum Therapeutics announced that ORLYNVAH is now available through McKesson, allowing physicians to procure the product directly via a specialty distribution channel.
FDA Clearance for Sulopenem Susceptibility Disc: The U.S. FDA has granted 510(k) clearance for Iterum's 2 microgram Antimicrobial Susceptibility Test Disc, which is now available for order and aids in determining the susceptibility of Enterobacterales to sulopenem.
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Analyst Views on ITRM
Wall Street analysts forecast ITRM stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ITRM is 5.50 USD with a low forecast of 2.00 USD and a high forecast of 9.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.322
Low
2.00
Averages
5.50
High
9.00
Current: 0.322
Low
2.00
Averages
5.50
High
9.00
About ITRM
Iterum Therapeutics plc is a clinical-stage pharmaceutical company. The Company develops differentiated anti-infectives. It offers ORLYNVAH (sulopenem in an oral tablet formulation) medicine, which is an oral penem antibiotic for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women. Sulopenem is a potent, thiopenem antibiotic delivered intravenously which is active against bacteria that belong to the group of organisms known as gram-negatives and cause urinary tract and intra-abdominal infections. The Company operates as a single business segment, which is the development and commercialization of treatments for drug-resistant bacterial infections.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Iterum Expands ORLYNVAH™ Coverage to 25 Million Lives in the U.S.
- Expanded Coverage: ORLYNVAH™ now reaches nearly 25% of insured lives in the U.S., with increasing integration into employer groups and payer formularies, which is expected to enhance market penetration significantly.
- Pharmacy Benefit Agreement: Iterum has signed a rebate agreement with a top Medicare Part D Pharmacy Benefit Manager, positioning ORLYNVAH™ for inclusion in their formularies starting Q1 2026, which will greatly improve product accessibility in the market.
- Increased Distribution Channels: ORLYNVAH™ is now stocked at additional distributors like Cencora, allowing physicians to procure the product through various channels, thereby enhancing market availability and procurement flexibility for doctors.
- Patent Expansion: The European Patent Office has indicated its intention to grant a patent covering a bilayer tablet of sulopenem etzadroxil and probenecid, projected to expire in December 2039, which strengthens Iterum's intellectual property protection in the anti-infective space.
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