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Securities Class Action: Spectrum Pharmaceuticals, Inc.

DATE: December 12, 2022

PHILADELPHIA, PA December 12, 2022Berger Montague advises investors that a securities fraud class action lawsuit has been filed against Spectrum Pharmaceuticals, Inc. (“Spectrum”) (NASDAQ: SPPI) on behalf of those who purchased Spectrum common stock during the period December 6, 2021 through September 22, 2022, inclusive (the “Class Period”).

Investor Deadline:  Investors who purchased or acquired Spectrum securities during the Class Period may, no later than February 3, 2023, seek to be appointed as a lead plaintiff representative of the class.  For additional information or to learn how to participate in this litigation, please contact Berger Montague: James Maro at [email protected] or (215) 875-3093, or Andrew Abramowitz at [email protected] or (215) 875-3015 or visit: https://investigations.bergermontague.com/spectrum-pharmaceuticals-inc/  

Spectrum purports to be a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. On December 6, 2021, Spectrum issued a press release announcing it submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for poziotinib’s use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. The NDA submission was based on purportedly “positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib.”

Starting on September 20, 2022, before the market opened, investors began to learn the truth when the FDA Oncologic Drugs Advisory Committee (“ODAC”) released a briefing document in anticipation of its September 22, 2022 meeting with the defendants to review poziotinib. ODAC is an independent panel of experts that reviews and evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer. Investors were surprised when, despite the company’s repeated representations during the Class Period that the data for ZENITH20 were positive, the ODAC briefing document disclosed not only negative data on the safety and efficacy of pozi, but also a failure by the company to enroll any patients in the required phase 3 confirmatory trial.

Then, on September 22, 2022, ODAC conducted its meeting concerning. During the meeting, ODAC voted 9-4 not to recommend poziotinib for Accelerated Approval.

A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the Court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.

 

 

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