Iterum Therapeutics Shares Latest Business Developments
ORLYNVAH™ Launch Update: Iterum Therapeutics has launched its antibiotic ORLYNVAH™ in the U.S. market, with sales representatives actively engaging physicians to promote the product, leading to initial prescriptions and interest from non-target physicians.
Market Access and FDA Clearance: The company is working on expanding access to ORLYNVAH™ through discussions with major health plans and has received FDA clearance for an antimicrobial susceptibility test disc, enhancing its capabilities in combating antimicrobial resistance.
Financial Outlook: Iterum expects its current cash reserves and recent fundraising efforts to sustain operations into 2026, while exploring additional financing options to extend its runway.
Patent Updates and Upcoming Presentation: Iterum has secured patents in China and Mexico for its antibiotic formulations, and will present at IDWeek 2025, focusing on urinary tract infections in adult women.
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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.






