Iterum Therapeutics (ITRM) title skyrockets in pre-market after NDA review update
What’s going on with ITRM?
Yesterday, May 27, Iterum Therapeutics (ITRM) announced an update on the treatment of oral urinary tract infections with the pharmaceutical company’s sulopenem etzadroxil / probenecid at the clinical stage. Iterum Therapeutics recently met with the United States Food and Drug Administration (FDA) regarding a new drug request (NDA) for this treatment. ITRM got a big boost during pre-market trading today, rising 23.58% to $ 1.52 per share.
What does this mean for Iterum Therapeutics?
Iterum Therapeutics, headquartered in Dublin, Ireland, met with the FDA at an end-of-cycle meeting to learn more about “the issues still under review regarding [Iterum Therapeutics’] new drug application for sulopenem etzadroxil / probenecid for the treatment of uncomplicated urinary tract infections in patients with a pathogen not sensitive to quinolones… ”according to a company Press release. Iterum Therapeutics responded to questions raised by the FDA, after which the FDA “determined that an advisory committee meeting was not required at this time.”
The FDA’s review of Iterum Therapeutics’ NDA continues, with the FDA working to establish a “deadline” for the Prescription Drug User Fee Act (PDUFA) of July 25, 2021.
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Iterum Therapeutics PLC is a pharmaceutical company. The company is engaged in the development and commercialization of sulopenem to be the first and only brand-name oral and intravenous penem available in the world. Its sulopenem program has the potential to offer a solution to the problem of antibiotic resistance and the limits of toxicity of existing agents.