
Kewaunee Scientific Corporation (KEQU)
Whether directors and officers of Kewaunee Scientific Corporation (KEQU) breached their fiduciary duties to the company and its shareholders.
Investigation
08/05/2021
Initial Lawsuit
08/05/2021
Lawsuit Progression
11/03/2021
Investigation regarding Iterum’s new drug application (NDA) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections (uUTIs).
07/26/2021
Iterum discloses that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem). The CRL provides that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its present form.
“In the CRL, the FDA acknowledged that the Phase 3 SURE-1 clinical trial demonstrated statistical significance in difference in overall response rate of oral sulopenem compared to ciprofloxacin in the ciprofloxacin-resistant population. However, 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. The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug. Additionally, the FDA recommended that Iterum conduct further nonclinical investigation to determine the optimal dosing regimen, although the FDA stated that this recommendation does not raise an approvability issue.“
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$0.63 | $1.13 | $-0.5 | -44.16% |
This is a federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Iterum securities between November 30, 2020 and July 23, 2021, both dates inclusive.
According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:
(i) the sulopenem NDA lacked sufficient data to support approval for the treatment of adult women with uUTIs caused by designated susceptible microorganisms proven or strongly suspected to be nonsusceptible to a quinolone;
(ii) accordingly, it was unlikely that the FDA would approve the sulopenem NDA in its current form;
(iii) Defendants downplayed the severity of issues associated with the sulopenem NDA;
(iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
11/03/2021
The court issued an order appointing the lead plaintiff and lead counsel.
01/26/2022
Lead plaintiffs bring this securities fraud class action on behalf of all purchasers of Iterum common stock between November 30, 2020 and July 26, 2021, inclusive.
Operative complaint
04/08/2022
A motion to dismiss was filed with the court.
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