Iterum slumps as FDA finds deficiencies in its antibiotic NDA

Ireland-incorporated superbug specialist Iterum Therapeutics (Nasdaq: ITRM) saw its shares close down a massive 38% at $1.42 on Friday, after it revealed another setback for its synthetic penem antibiotic candidate.

Iterum said it has received a letter from the US Food and Drug Administration 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.