Inari Medical, Inc. (NARI)
Whether directors and officers of Inari Medical, Inc. (NARI) breached their fiduciary duties to the company and its shareholders.
Investigation
11/26/2021
Initial Lawsuit
02/09/2022
Lawsuit Progression
05/09/2022
This investors investigation follows Fennec’s disclosures of a CRL regarding the Pedmark NDA and deficiencies found at a pre-approval inspection of its manufacturing facility.
11/29/2021
Fennec announces that it expects to receive a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARK for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥1 month to 18 years of age with localized, non-metastatic, solid tumors.
“The FDA has indicated that, following a recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, deficiencies have been identified. Once the official CRL is received, the Company plans to request a Type A meeting to discuss the deficiencies and steps required for the resubmission of the NDA for PEDMARKTM.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$4.78 | $9.64 | $-4.86 | -50.41% |
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 Fennec securities between May 28, 2021 and November 26, 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) Fennec had not successfully remediated, and overstated its efforts to remediate, issues with the manufacturing facility of its drug product manufacturer for PEDMARK;
(ii) as a result, the FDA was unlikely to approve the Resubmitted Pedmark NDA;
(iii) accordingly, the regulatory and commercial prospects of the Resubmitted Pedmark NDA were overstated; and
(iv) as a result, the company’s public statements were materially false and misleading at all relevant times.
05/09/2022
The court issued an order appointing the lead plaintiff and lead counsel.
06/23/2022
Operative complaint
Whether directors and officers of Inari Medical, Inc. (NARI) breached their fiduciary duties to the company and its shareholders.
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