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VERU.US
id: 488

Christopher K. Ewing, et al. v. Veru Inc. Case

S.D. Florida
Court
On November 9, 2022, the FDA Pulmonary-Allergy Drugs Advisory Committee voted against granting Veru’s EUA request for sabizabulin. One Committee member explained that there was “no direct evidence to support sabizabulin’s antiviral activity.

On this news, VERU's stock price dropped over 53%, wiping out over $640 million in market capitalization.

Going back on August 11, 2022, Veru filed its Quarterly Report with the SEC, which stated that during the May 10, 2022, pre-EUA meeting, the FDA had “agreed that no additional efficacy studies were required to support a EUA application or a new drug application (NDA)” for sabizabulin, that “no additional safety data was required,” and that “the FDA agreed that the request for the EUA is supported by efficacy and safety data from our positive Phase 3 COVID-19 study . . . and no additional clinical trials are required to support an NDA submission.”

Taking all public representation into account, Veru's investors have grounds to suspect that one or more involved parties grossly breached their fiduciary duties to the Company's shareholders.
Case Status
Attorney Investigation
Alleged Offence
Misleading Statements
Failure to Disclose
Malpractice
Negligence
Omissions
Suspected Party
Directors
Management
Government Authority
Service Provider
Security Type
Stocks
Trade Direction
Long
Shock Event Date
11/09/2022
Filing date
12/05/2022
Judge
Hon. Joan A. Lenard
Collecting participants…

Veru Inc

Veru Inc., a late clinical stage biopharmaceutical company, focuses on developing medicines for treatment of metabolic diseases, oncology, and acute respiratory distress syndrome (ARDS). Its market...

    Ticker
    VERU.US
    ISIN
    US92536C1036
    CIK
    863894
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    2916 North Miami Avenue, Miami, FL, United States, 33127