Iterum Therapeutics (NASDAQ:ITRM)announced an update on the company's Type A meeting with the U.S. FDA related to the NDA for its sulopenem etzadroxil/probenecid (oral sulopenem), and provided an update on its cash position.
The NDA for sulopenem etzadroxil/probenecid (oral sulopenem) is for the treatment of uncomplicated urinary tract infections ((uUTI)).
In July, the company had received a Complete Response Letter (CRL) from the FDA requesting additional data to support approval of oral sulopenem for the treatment of adult women with a uUTI.
"We had a successful meeting with the FDA and have established various potential paths forward to address the request in the CRL for additional data in support of our NDA," CEO Corey Fishman said.
"We are currently evaluating the optimal design for an additional Phase 3 uUTI study to be conducted prior to the potential resubmission of the NDA," he added.
Iterum notes that cash, cash equivalents and short-term investments were $91.5M at the end of the second quarter of 2021.
The company believes that it is well positioned financially to fund its operations into the second half of 2023.