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.
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