Iterum Therapeutics plc (NASDAQ:ITRM) Stock Attempts To Recover From The Recent Slump
Iterum Therapeutics plc (NASDAQ:ITRM) ITRM jumped 9%, but it is down 40% in the past month. The company announced that the FDA had issued a letter indicating that as part of its ongoing review of Iterum’s NDA for sulopenem etzadroxil/probenecid, some deficiencies precluded talks on labeling and post-marketing commitment/requirements for now.
The company has not offered details regarding the deficiencies identified by the FDA in the notification letter, which further indicated that the notification would not reflect an outcome on the information currently under review. CEO Corey Fishman said that although the news is disappointing, the company believes in sulopenem’s potential to address the antibiotic resistance challenge.
In May, the company announced that it met the US FDA in a late-cycle meeting to discuss issues under review about its new drug application for sulopenem for uncomplicated urinary tract infection treatment in patients with quinolone non-susceptible pathogen. The company responded to the issues, and the agency determines that there was no need for an Advisory Committee. So in the coming months, ITRM is a stock to watch.
Market Reaction:
On Wednesday, ITRM stock jumped 9% at $1.22 with more than 16.12 million shares, compared to its average volume of 12.64 million shares. The stock has moved within a range of $1.1100 – 1.3500 after opening the trade at $1.12. Over the past 52-week, the stock has been trading within a range of $0.4510 – 2.9950.
