- Iterum Therapeutics plc (NASDAQ: ITRM) shares dropped after the company in an SEC filing disclosed that the FDA needs additional time to review its sulopenem application.
- The application seeks approval for sulopenem etzadroxil/probenecid for uncomplicated urinary tract infection.
- Hence, FDA Antimicrobial Drugs Advisory Committee June 2 meeting has been postponed.
- The new date for the Panel review of the company’s application is not confirmed, and the company continues to work closely with the FDA to facilitate its review.
- Price Action: ITRM shares are down 17.7% at $1.325 in market trading hours on the last check Friday.
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