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YMAB.US
id: 549

Y-mAbs Therapeutics Negligence Case

S.D. New York
Court
23-CV-00431
Case number
21 Mar 2023
Lead Plaintiff motion deadline
On October 28, 2022, the FDA’s Oncologic Drugs Advisory Committee voted unanimously against approving the Y-mAbs’s (NASDAQ: YMAB) marketing application for omburtamab.

On this news, Y-mAbs’s stock price dropped over 59%, seriously damaging investors.

Earlier on October 26, 2022, the FDA released briefing documents expressing concerns that the Biologics License Application for the Company’s product candidate does not provide sufficient evidence of efficacy.  The FDA cited the fact that the Company submitted data:
  • from just a single center, single-arm trial;
  • that additional analyses conducted by the FDA to examine bias and results found that differences in survival cannot be reliably attributed to omburtamab;
  • and that the application does not include reliable response rate data to provide supportive evidence of the treatment effect of omburtamab.
On this news, YMAB's price fell over 27%.

Taking the nature of the issues into account, Investors have all reasons to suspect that the Company and its Leaders did not conduct the due performance of their work, which led to rejected application with the FDA.
Alleged Offence
Mismanagement
Misleading Statements
Malpractice
Negligence
Breach of Fiduciary duty
Omissions
Suspected Party
Directors
Management
Government Authority
Service Provider
Research Entity
Security Type
Stocks
Trade Direction
Long
Shock Event Date
28 October 2022
Lead Plaintiff Deadline
21 March 2023
Collecting participants…

Y mAbs Therapeutics

Y-mAbs Therapeutics, Inc., a commercial-stage biopharmaceutical company, focuses on the development and commercialization of novel antibody based therapeutic products for the treatment of cancer in...

    Ticker
    YMAB.US
    ISIN
    US9842411095
    CIK
    1722964
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    230 Park Avenue, New York, NY, United States, 10169