Spectrum Pharmaceuticals, Inc. (SPPI) Materially Misrepresented the Likelihood ROLONTIS Would be Approved by the FDA
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.
If you purchased shares of Spectrum Pharmaceuticals, Inc. (SPPI) securities between December 27, 2018 and August 5, 2021, you have until November 1, 2021, to ask the court to appoint you lead plaintiff for the class.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.