Robbins LLP: Spectrum Pharmaceuticals, Inc. (SPPI) Misled Shareholders According to a Recently Filed Class Action
Robbins LLP announces that a class action complaint was filed against Spectrum Pharmaceuticals, Inc. (NASDAQGS: SPPI) in the U.S. District Court for the Central District of California. The complaint is brought on behalf of all purchasers of Spectrum securities between December 16, 2015 and September 16, 2016, for alleged violations of the Securities Exchange Act of 1934 by Spectrum’s officers and directors. Spectrum is a biotechnology company that develops and commercializes oncology and hematology drug products. One of the company’s primary products is apaziquone, which is being developed to treat non-muscle invasive bladder cancer.
Spectrum Accused of Concealing Critical Information from the FDA
According to the complaint, in 2007, Spectrum began its Phase 3 Studies for apaziquone—known as the 611 Study and the 612 Study—each of which enrolled patients who took apaziquone and a placebo. Spectrum submitted a New Drug Application (“NDA”) for apaziquone to the U.S. Food and Drug Administration (“FDA”) on December 11, 2015. Subsequently, Spectrum specified that the drug was extremely safe and that the study data from its Phase 3 trials were highly significantly positive. On May 5, 2016, the company held a conference call, stating that it was expecting an FDA decision on the apaziquone NDA by December 11, 2016. The complaint alleges, however, that Spectrum officials failed to disclose that: (1) the FDA previously questioned whether the data from the 611 and 612 Studies were clinically meaningful; (2) the FDA advised Spectrum officials in December 2012 not to submit the NDA based on data from the 611 and 612 Studies; and (3) as a result, Spectrum’s public statements about its business, operations, and prospects were false and misleading.
On September 14, 2016, Spectrum issued a press release stating that apaziquone had not shown substantial evidence of treatment versus a placebo. On the same day, the FDA published the FDA’s Briefing Document from Oncologic Drugs Advisory Committee Meeting on Spectrum’s apaziquone NDA on its website, which stated that Spectrum was aware of faulty data it submitted in the NDA in 2012. Then, on September 16, 2016, The Street published an article discussing how Spectrum officials a hid from investors a key detail from a December 2012 meeting with the FDA in which regulators told the company not to seek approval for a bladder cancer drug because two clinical trials failed to benefit patients. On this news, Spectrum stock fell $0.13 per share, or over 2.6%, to close at $4.72 per share on September 19, 2016.
Spectrum Shareholders Have Legal Options
Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.
