Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc. (“Spectrum”) is a biopharmaceutical company that develops and commercializes oncology and hematology drug products.
In December 2018, Spectrum submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for ROLONTIS (eflapegrastim) as a treatment for chemotherapy-induced neutropenia.
On August 6, 2021, Spectrum announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding the BLA, citing deficiencies related to manufacturing and requiring a reinspection of the Company’s manufacturing facility.
On this news, Spectrum’s stock price fell $0.70 per share, or nearly 22%, to close at $2.55 per share on August 6, 2021.
A securities class action has been filed against Spectrum on behalf of shareholders that purchased Spectrum shares between December 27, 2018 through August 5, 2021. This case has been filed in the U.S. District Court for the District of Nevada.
The Complaint alleges that defendants, throughout the Class Period, made false and/or misleading statements and/or failed to disclose that: (1) the manufacturing facility of ROLONTIS maintained deficient controls and/or procedures; (2) the foregoing deficiencies decreased the likelihood that the FDA would approve the ROLONTIS BLA in its current form; (3) Spectrum had therefore materially overstated the ROLONTIS BLA’s approval prospects; and (4) as a result, the Company’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
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