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Case Status:    DISMISSED  
—On or around 02/13/2020 (Court's order of dismissal)
Current/Last Presiding Judge:  
Hon. Richard Seeborg

Filing Date: April 12, 2019

According to the Complaint, Zogenix, Inc. is a pharmaceutical company that develops and commercializes therapies for the treatment of transformative central nervous system disorders in the United States. Its lead product candidate is ZX008, which is also known commercially by its trademarked name “FINTEPLA.” FINTEPLA is a low-dose fenfluramine that is in Phase III clinical trials for the treatment of seizures associated with Dravet syndrome.

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) Zogenix’s NDA for FINTEPLA contained inadequate non-clinical data and an incorrect version of a clinical dataset; (ii) consequently, Zogenix’s NDA for FINTEPLA was unlikely to gain FDA approval; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On July 19, 2019, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on September 10. Defendants filed a Motion to Dismiss the amended Complaint on October 4. On January 27, 2020, the Court issued an Order dismissing the amended Complaint with leave to amend. On February 13, Lead Plaintiff voluntarily dismissed this case.

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