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SPPI.US
id: 490

Enrique Osorio-Franco, et al. v. Spectrum Pharmaceuticals Case

S.D. New York
Court
On September 22, 2022, the FDA Oncologic Drugs Advisory Committee(ODAC) voted 9-4 not to recommend Spectrum's (SPII) poziotinib for Accelerated Approval.

  • On September 23, 2022, H.C. Wainwright released a report titled “ODAC Votes Against Poziotinib; Debt Deal Announced; Lower PT by $3”. The report noted that the 9 “no” voters from the ODAC cited “non-meaningful benefit over existing therapies and cited dosing issues… Issues related to the Phase 3 confirmatory trial for poziotinib were also raised… as that study has not yet started.”
  • Going back through 2021 -2022, the Company and its Leaders represented the safety and efficacy data from the ZENITH20 trial were positive and that they had initiated the required confirmatory phase 3 study.
Taking all representations into account, Investors have reasons to suspect that they were misled by the Company and its management on the prospects of its drug candidate.
Case Status
Attorney Investigation
Alleged Offence
Misleading Statements
Failure to Disclose
Negligence
Omissions
Suspected Party
Directors
Management
Government Authority
Service Provider
Security Type
Stocks
Trade Direction
Long
Shock Event Date
22 September 2022
Filing date
05 December 2022
Judge
Hon. Valerie E. Caproni
Collecting participants…

Spectrum Pharmaceuticals Inc

Spectrum Pharmaceuticals, Inc., a biopharmaceutical company, develops and commercializes oncology drug products. It offers ROLVEDON(Eflapegrastim), a novel long-acting granulocyte colony-stimulatin...

    Ticker
    SPPI.US
    ISIN
    US84763A1088
    CIK
    831547
    Sector
    Healthcare
    Industry
    Biotechnology & Medical Research
    Country
    USA
    Address
    Pilot House ? Lewis Wharf, Boston, MA, United States, 02110