Iterum Therapeutics (ITRM)

[Phoenix300]

NDA accepted for priority review by FDA with PDUFA goal date of July 25, 2021: In January 2021, the FDA accepted for review our NDA for uUTI in patients with a quinolone non-susceptible organism. The FDA has designated our application as a priority review and consequently assigned a PDUFA goal date for completion of the review of oral sulopenem of July 25, 2021. The FDA currently plans to hold an advisory committee meeting to discuss the NDA on June 2, 2021.