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ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down [Yahoo! Finance]
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its new drug application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. The FDA held the AMDAC meeting on Sept. 9, to discuss the overall benefits and risks of oral sulopenem in treating uUTIs in women aged more than 18 years and important factors for medical providers to know to ensure the proper use of sulopenem. The FDA did not urge the AMDAC to vote on any matter. Per some market reports, sulopenem's off-label use for treating uUTIs could be attached to a degree of high risk. There are chances that sulopenem will be approved with certain limitations. In such a scenario, a post-marketing study would be imperative to confirm sulopenem's proper use and label. This might have hurt investors' sentiments and resulted in the stock going down 12% on Sept. 10 following the announcement of the news. Shares of Iterum have plunged 51.8% so far this year compared with the industry's decrease of 0.8%. Image Source: Zack
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