Iterum Announces ORLYNVAH Reimbursement Coverage Near 25%
The company said, "Market Access Update: Expanding Reimbursement Footprint: ORLYNVAH's access continues to grow-both with and without prior authorization or medical exception pathways, allowing coverage approval for many of the ORLYNVAH prescriptions written to date. Current coverage now reaches nearly 25% of insured lives in the U.S., with increasing adoption by employer groups and payer formularies integrating ORLYNVAH into standard benefit designs on a weekly basis. Based on publicly available data sources, more than 60 million insured lives now have reimbursement access to ORLYNVAH through a variety of health plan benefit designs. This includes coverage under California and New York State Medicaid programs, certain Veterans Affairs/Tricare affiliates, and lines of business within Blue Cross Blue Shield plans, Aetna and others. Medicare Part D Milestone: We are pleased to announce a signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers. This agreement positions ORLYNVAH for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage expected to begin as early as Q1 2026. Key Pharmacy Benefit Manager Status: Iterum has submitted bids at the major Pharmacy Benefit Manager organizations across commercial, Medicare and Government plans, and is aiming to secure long term formulary positioning this year and into Q1 2026. Additional Specialty Distributor Now Stocked: In addition to ORLYNVAH being stocked at McKesson, ORLYNVAH is now available at Cencora. Having product available at these distributors will allow certain physicians to procure the product directly through these channels, as it fits within their practice preferences. Expansion of Patent Estate: The European Patent Office has issued a Communication under Rule 71(3) EPC indicating its intention to grant a patent from European Patent Application No. 19832143.2, entitled "combinations of beta-lactam compounds and probenecid and uses thereof", that covers a bilayer tablet of sulopenem etzadroxil and probenecid, methods of preparing the bilayer tablet, and the bilayer tablet for use in treating specified diseases. Upon issuance, the patent will be projected to expire in December 2039, absent any extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent."
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- Cost-Cutting Measures: The company is evaluating further reductions in force and other measures to significantly cut operating expenses, aiming to enhance financial flexibility and pave the way for future strategic options.
- Speculative Trading: Cue Biopharma's stock rose 10.67% to $0.42 despite no new company news, suggesting speculative trading activity may reflect investor optimism in the biotech sector.
- Continued Growth Trend: InfuSystem and Cabaletta Bio saw stock increases of 7.19% and 7.68%, respectively, demonstrating ongoing investor interest in the medical services and biotech sectors, despite the absence of new corporate updates.
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- 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.
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