Spectrum Pharmaceuticals, Inc. (SPPI) Accused of Materially Misrepresenting the Likelihood ROLONTIS Would be Approved by the FDA
A class action was filed on behalf of all persons and entities that purchased or otherwise acquired Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) securities between December 27, 2018 and August 5, 2021, for violations of the Securities Exchange Act of 1934. Spectrum is a biopharmaceutical company that develops and commercializes oncology and hematology drug products. One product the Company has under development is ROLONTIS (eflapegrastim), a novel long-lasting granulocyte colony-stimulating factor for chemotherapy-induced neutropenia.
According to the complaint, Spectrum submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for ROLONTIS as a treatment chemotherapy-induced neutropenia (the “ROLONTIS BLA”) in December 2018. In March 2019, Spectrum voluntarily withdrew its ROLONTIS BLA, and then resubmitted an updated ROLONTIS BLA in October 2019. During the relevant period, defendants touted the viability of ROLONTIS and the preparations the Company had made in advance of the FDA’s inspection of its manufacturing facility. However, defendants made materially false and misleading statements and/or failed to disclose that the ROLONTIS manufacturing facility maintained deficient controls and/or procedures and that the deficiencies decreased the likelihood that the FDA would approve the ROLONTIS BLA in its current form. As a result, Spectrum had materially overstated the ROLONTIS BLA’s approval prospects.
On August 6, 2021, Spectrum announced receipt of a Complete Response Letter (“CRL”) from the FDA regarding the ROLONTIS BLA. The CRL cited deficiencies related to manufacturing and indicated that a reinspection of the Company’s manufacturing facility would be necessary. On this news, Spectrum’s stock price fell $0.70 per share, or over 21%, to close at $2.55 per share on August 6, 2021.
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