Shares of Iterum Therapeutics plc (ITRM) - Get Iterum Therapeutics Plc Report dropped Monday after the company announced that it will not get approval for the current form of its new drug application for oral sulopenem.
The Food and Drug Administration determined that additional data are necessary while recommending that the company conduct at least one more well-controlled clinical trial for its treatment of adult women with uncomplicated urinary tract infections.
“We are disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” said CEO Corey Fishman. "Regardless, we will evaluate the points raised in the CRL for discussion with the FDA to determine an expeditious path forward."
Iterum shares were falling 40% to 67 cents per share Monday at last check.
The company says that it remains confident in the value of its treatment due to the unmet medical need for oral sulopenem.
The FDA sent Iterum a complete response letter in response to the company's new drug application on July 23. The government agency says it is willing to work with Iterum on the design of clinical trials in order to address the issues the FDA identified.
Earlier this month, Iterum said it received a letter from the FDA saying that there were deficiencies found it its treatment for UTIs.
In a Jan. 21 letter to the company, “the FDA had assigned a Prescription Drug User Fee Act goal date of July 25 for completion of its review of the NDA,” Iterum said.