Iterum Therapeutics (NASDAQ:ITRM) stock is taking off on Monday as investors react to news of a clinical trial agreement with the U.S. Food and Drug Administration (FDA).
This agreement has to do with the company’s plans for a Phase 3 clinical trial of oral sulopenem etzadroxil-probenecid. This is a drug designed to treat patients that are suffering from uncomplicated urinary tract infections.
The special protocol assessment (SPA) agreement sets up specific parameters for the Phase 3 clinical trial. The goal is to meet the requirements the FDA has listed for the resubmission of Iterum Therapeutics’ New Drug Application (NDA) for the treatment.
Corey Fishman, CEO of Iterum Therapeutics, said the following in a news release.
“The SPA underscores our alignment with the FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial in uUTI and reflects our ongoing commitment to bring this valuable therapy to market. We are excited about this important milestone and are looking forward to starting recruitment for this trial as soon as possible.”
News of the FDA agreement has ITRM stock seeing heavy trading on Monday. As of this writing, some 86 million shares of the stock have changed hands. That’s a massive leap over its daily average trading volume of about 1.1 million shares.
ITRM stock is up 72.5% as of Monday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
