SAN FRANCISCO, Oct. 05, 2016 (GLOBE NEWSWIRE) -- Hagens Berman Sobol Shapiro LLP alerts investors in Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) to the expanded class period in the Nevada U.S. District Court case against Spectrum Pharmaceuticals, Inc. and the November 21, 2016 lead plaintiff deadline for the Spectrum lawsuits in Nevada and the Central District of California.
If you purchased or otherwise acquired securities of SPPI between February 28, 2013 and September 16, 2016 and suffered over $50,000 in losses contact Hagens Berman Sobol Shapiro LLP. For more information visit:
https://www.hbsslaw.com/cases/SPPI
or contact Reed Kathrein, who is leading the firm’s investigation, by calling 510-725-3000 or emailing SPPI@hbsslaw.com.
During a December 2012 meeting with the U.S. Food and Drug Administration (FDA), the FDA discouraged Spectrum from submitting a New Drug Application (NDA) for apaziquone (branded as Qapzola) for the treatment of bladder tumors in patients with non-muscle invasive bladder cancer. The FDA noted that apaziquone’s clinical trials showed the drug “did not meet the pre-specified criteria for superiority when compared to placebo[.]”
In December 2015, Spectrum submitted an apaziquone NDA with the same clinical trials that the FDA previously discouraged. The Company then repeatedly discussed apaziquone’s NDA status during earnings conference calls but never disclosed the FDA’s prior discouragement. On September 14, 2016, Spectrum disclosed that the FDA’s panel of outside experts found apaziquone had “not shown substantial evidence of a treatment effect over placebo.” Spectrum shares fell 8% to close at $5.04.
When TheStreet later reported “Spectrum joins an unacceptably long list of drug and biotech companies hurting investors by failing to be fully transparent about their communications with the FDA,” the price of Spectrum shares fell another 2.6%.
“We are investigating the key details of apaziquone and the Company’s dealings with the FDA that Defendants allegedly failed to disclose,” said Hagens Berman partner Reed Kathrein.
Whistleblowers: Persons with non-public information regarding Spectrum Pharmaceuticals should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new SEC whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 510-725-3000 or email SPPI@hbsslaw.com.
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