Iterum Therapeutics Stock Plunges After FDA Rejects Its Sulopenem Application

Iterum Therapeutics plc ITRM has received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval for sulopenem etzadroxil/probenecid (oral sulopenem).
The FDA determined that additional data are necessary to support approval for the treatment of adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone (board-spectrum antibiotic).
The agency has asked for at least one additional clinical trial, potentially using a different comparator drug, and conduct a further non-clinical investigation to determine the optimal dosing regimen.
There were no chemistry, manufacturing, or controls issues identified in the CRL, nor were there any safety issues.
Iterum plans to request a Type A meeting in the coming weeks. Following the Type A meeting anticipated to be in late Q3, it expects to update the next steps.
Iterum notes that cash, cash equivalents, and short-term investments were $100.5 million sufficient to fund its operations into the second half of 2023.
Price Action: ITRM shares are down 43.30% at $0.64 during the premarket session on the last check Monday.
Related content: Benzinga's Full FDA Calendar.