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Stock Market & Financial Investment News

News Breaks
July 7, 2014
07:02 EDTSPPISpectrum granted accelerated approval for Beleodaq from FDA
Spectrum Pharmaceuticals announced that the U.S. Food and Drug Administration has granted accelerated approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq was approved by the FDA on July 3. This indication was approved based on data from the multi-center, single-arm BELIEF trial in 120 evaluable patients, refractory to or who had failed at least one prior systemic therapy. In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity. A review of data from a planned confirmatory Phase III trial of Beleodaq in combination with CHOP to characterize the efficacy and safety of the Beleodaq combination versus CHOP alone, is required by FDA to convert this accelerated approval to a full approval.
News For SPPI From The Last 14 Days
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May 14, 2015
07:01 EDTSPPISpectrum commits to review shareholder proposal
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May 12, 2015
12:34 EDTSPPIOn The Fly: Top stock stories at midday
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06:16 EDTSPPIArmistice calls for full or partial sale of Spectrum
Armistice Capital reported a 5.4% stake in Spectrum Pharmaceuticals and disclosed a letter it sent to the company's Chairman and CEO Rajesh Shrotriya as well as its board. In the letter, Armistice stated its view that Spectrum "continues to underperform its peers and that a number of opportunities exist to rectify this underperformance and create significant value for shareholders." Armistice detailed "action that management should take to reduce operating expenses, restructure the Issuer's operations to enhance efficiency and better align the incentives of management with shareholders." Armistice believes Spectrum "can create significant value for shareholders through a combination of reducing management compensation and employee headcount, significantly curtailing research and development, eliminating excessive corporate offices, and focusing on in-licensing and co-promotion opportunities." Further, Armistice requests that Spectrum initiate a complete or partial sale of the company. Shares of the biotechnology company focused on hematology and oncology closed yesterday up 38c to $6.06.

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