Iterum Therapeutics expects to resubmit oral sulopenem NDA in 1H of 2Q24

Iterum Therapeutics provided a general business update. Iterum announced that it now expects to resubmit its new drug application for oral sulopenem to the U.S. Food and Drug Administration in the first half of the second quarter of 2024, earlier than originally planned. Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA. Based on Iterum’s current operating plan, Iterum believes that its existing cash and cash equivalents and short-term investments as of December 31, 2023, together with the net proceeds from the sale of ordinary shares under its “at-the-market” offering agreement through February 29, 2024, are expected to enable it to fund its operating expenses into 2025, including through the expected Prescription Drug User Fee Act date in the first half of the fourth quarter of 2024. In January 2024, Iterum announced positive top-line results from the REASSURE trial and that it would be focusing on a strategic process to sell, license, or otherwise dispose of its rights to sulopenem with the goal of maximizing value for its stakeholders. Iterum plans to engage a financial advisor in the near-term to assist management and the Board in evaluating Iterum’s strategic alternatives.