Stock Alert: Iterum Soars 165% On Positive Pre-NDA Meeting With FDA For Urinary Infections Treatment

(RTTNews) - Shares of Iterum Therapeutics plc (ITRM) skyrocketed over 165% on Wednesday morning after the company announced positive pre-NDA meeting with FDA for Sulopenem for treatment of urinary tract infections.

ITRM is currently trading at $1.73, up $1.0856 or 168.47%, on the Nasdaq.

The clinical-stage pharmaceutical company announced that, based on discussions at a pre-NDA meeting with the FDA, it plans to proceed with an NDA submission for sulopenem etzadroxil/probenecid, a bilayer tablet, for the treatment of uncomplicated urinary tract infections in patients with a quinolone-resistant pathogen.

"We are pleased with the collaborative tone of our meeting with the FDA, and we believe that we now have a solid understanding of the Agency's requirements for our submission and the focus of their review," said Corey Fishman, Chief Executive Officer.