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Case Page

 

Case Status:    SETTLED  
—On or around 06/16/2025 (Settlement preliminarily approval)
Current/Last Presiding Judge:  
Hon. Cristina D. Silva

Filing Date: August 31, 2021

According to the Complaint, Spectrum Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes oncology and hematology drug products. The Company’s products under development include, among others, ROLONTIS (eflapegrastim), a novel long-acting granulocyte colony-stimulating factor for chemotherapy-induced neutropenia.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose 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.

On July 28, 2022, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended consolidated Complaint on September 26. Defendants filed a Motion to Dismiss the amended consolidated Complaint on November 30. On February 6, 2024, the Court granted Defendants' Motion to Dismiss. Plaintiff was given leave to amend the Complaint.

On March 29, 2024, Lead Plaintiff filed a second amended consolidated Complaint. Defendants filed a Motion to Dismiss the second amended consolidated Complaint on May 13. On October 7, the Court issued an Order granting in part and denying in part Defendants' Motion to Dismiss. The matter was referred to the Magistrate Judge for a settlement conference.

On May 9, 2025, the parties entered into a Stipulation of Settlement. The Court granted preliminary approval of the Settlement on June 16.

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