Iterum Therapeutics shares rise 14.63% intraday after FDA clears sulopenem test disc and ORLYNVAH stocked at McKesson.

Iterum Therapeutics surged 14.63% intraday following two key announcements. The company confirmed that its antibiotic ORLYNVAH is now stocked at McKesson, a major specialty distributor, enabling physicians to procure the drug directly through this channel. Additionally, the FDA granted 510(k) clearance for a 2 µg sulopenem antimicrobial susceptibility test disc, manufactured by Liofilchem, to assess Enterobacterales resistance to sulopenem. These developments mark critical commercialization steps, enhancing clinical adoption and antimicrobial stewardship integration. The McKesson distribution agreement broadens market access, while the FDA-cleared test disc provides a standardized tool for labs to guide targeted therapy, addressing antimicrobial resistance. Both milestones signal regulatory and operational progress for Iterum’s core product, ORLYNVAH, which is positioned as a novel oral penem antibiotic for urinary tract infections. The stock’s sharp intraday rise aligns with investor optimism over these near-term catalysts and their potential to drive revenue growth.