Iterum Stock Nosedives As FDA Flags Deficiencies In Sulopenem Application

by Vandana Singh, Benzinga Editor

July 2, 2021 7:33 AM | 1 min read |

Iterum Therapeutics plc ITRM has received a letter from the FDA regarding the sulopenem etzadroxil/probenecid marketing application review for uncomplicated urinary tract infections.
The agency has identified deficiencies that preclude the discussion of labeling and post-marketing requirements/commitments at this time.
The FDA did not disclose the details regarding deficiencies in this notification. The letter further states that the notification does not reflect a final decision on the information under review.
The FDA has assigned a goal date of July 25 for completion of its review of the NDA.
The company said it intends to work with the FDA to understand the nature of the deficiencies and resolve them soon.
Price Action: ITRM shares are down 39.7% at $1.38 during the premarket session on the last check Friday.

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