Spectrum Pharmaceuticals, Inc.

  • Active

Investigation
08/31/2021

Initial Lawsuit
08/31/2021

Lawsuit Progression
07/28/2022

Investigation

  • Continous Holding
    December 27, 2018 to August 5, 2021
  • Proposed Claim
    Securities Violation

Did Spectrum Pharmaceutical, Inc. (SPPI) mislead investors about manufacturing deficiencies? Did the company make false and misleading statements prior to the receipt of a Complete Response Letter (CRL) from the FDA about ROLONTIS Biologics License Application (BLA)?

This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.

A lawsuit was subsequently filed. We will update this post as it unfolds.

Main Event

FDA Complete Response Letter

08/06/2021

Company Statement

Spectrum Pharmaceuticals announces receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for ROLONTIS (eflapegrastim).

“The CRL cited deficiencies related to manufacturing and indicated that a reinspection will be necessary. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$2.55 $3.25 $-0.7 -21.54%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 08/31/2021

A Spectrum Pharmaceuticals, Inc. (SPPI) investor filed a federal securities class action lawsuit on behalf of a class consisting of all persons and entities (other than defendants) that purchased or otherwise acquired Spectrum securities between December 27, 2018, and August 5, 2021, both dates inclusive.

  • Filing Date
    08/31/2021
  • Class Period
    12/27/2018 to 08/05/2021
  • Transgression
    Securities Violation
  • Filing Firms
    Pomerantz LLP
    Muehlbauer Law Office, Ltd.
  • Case Title
    Luo v. Spectrum Pharmaceuticals, Inc. et al
  • Docket Number
    2:21-cv-01612
  • Court
    Nevada District Court
  • Free File
    Complaint

Allegations

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) the ROLONTIS manufacturing facility maintained deficient controls and/or procedures;
(ii) the foregoing deficiencies decreased the likelihood that the FDA would approve the ROLONTIS BLA in its current form;
(iii) Spectrum had therefore materially overstated the ROLONTIS BLA’s approval prospects; and
(iv) as a result, the company’s public statements were materially false and misleading at all relevant times.

Defendants

  • Company
    Spectrum Pharmaceuticals, Inc.
  • Chief Executive Officer
    Joseph W. Turgeon
  • Chief Financial Officer
    Kurt A. Gustafson
  • Chief Medical Officer
    Francois Lebel

Lawsuit progression

  • Docket Number
    2:21-cv-01612
  • Court
    Nevada District Court

Lead Counsel

07/28/2022

The court issued an order appointing the lead plaintiff and lead counsel.

  • Lead Counsel
    Robbins Geller Rudman & Dowd LLP
  • Lead Plaintiff
    Company
  • Free File
    Order for lead
[stockdio-historical-chart symbol=”SPPI” stockExchange=”NYSENasdaq” width=”500″ height=”330″ motif=”blinds” palette=”humanity” includeVolume=false]

Factual Timeline

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