Iterum Therapeutics PLC (NASDAQ:ITRM) stock is the biggest loser in the pre-market session after the regulatory update.
Market Action
As of 4:20, ITRM stock slumped 33% to $1.53 in the pre-market session.
Major Trigger:
Iterum Therapeutics Provides Regulatory Update
Key Highlights:
- Iterum Therapeutics announced that the Company received a letter from the U.S. Food and Drug Administration (“FDA”) stating that, as part of their ongoing review of the Company’s New Drug Application (“NDA”) for sulopenem etzadroxil/probenecid, the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time.
- No details with respect to deficiencies were disclosed by the FDA in this notification and the letter further states that the notification does not reflect a final decision on the information under review. In a letter to the Company dated January 21, 2021, the FDA had assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 25, 2021 for completion of its review of the NDA.
- The Company intends to work with the FDA to understand the nature of the deficiencies and resolve them as quickly as possible.
Key Quote:
“While we are disappointed by this news, we continue to believe in the potential of sulopenem to help address the growing challenge of antibiotic resistance,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “Our goal now is to work with the FDA to identify and resolve the issues as expeditiously as possible in order to continue advancing this much needed antibiotic.”
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