NEW YORK, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against Spectrum Pharmaceuticals, Inc. (“Spectrum Pharmaceuticals” or the “Company”) (NASDAQ: SPPI) in the United States District Court for the District of Nevada on behalf of those who purchased or otherwise acquired Spectrum Pharmaceuticals publicly traded securities between December 27, 2018 and August 5, 2021, inclusive (the “Class Period”).
Spectrum Pharmaceuticals is a biopharmaceutical company whose products under development include, among others, ROLONTIS (eflapegrastim), a novel long-acting granulocyte colony-stimulating factor for chemotherapy-induced neutropenia. In December 2018, Spectrum Pharmaceuticals submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for ROLONTIS as a treatment for chemotherapy-induced neutropenia (the “ROLONTIS BLA”).
The Complaint alleges that Defendants made false and misleading statements and failed to disclose that: (1) the ROLONTIS manufacturing facility 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 Pharmaceuticals had therefore materially overstated the ROLONTIS BLA’s approval prospects; and (4) as a result, Spectrum Pharmaceuticals’ public statements were materially false and misleading at all relevant times.
On August 6, 2021, Spectrum Pharmaceuticals 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 Spectrum Pharmaceuticals’ manufacturing facility will be necessary. On this news, Spectrum Pharmaceuticals’ stock price fell more than 21%, damaging investors.
Investors who purchased or otherwise acquired shares of Spectrum Pharmaceuticals during the Class Period should contact the Firm prior to the November 1, 2021 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
Please visit our website at http://www.gme-law.com for more information about the firm.
