spectrum pharmaceuticals inc (SPPI) Key Developments
Spectrum Pharmaceuticals, Inc. Receives FDA Approval for New Drug Application of Beleodaq
Jul 3 14
Spectrum Pharmaceuticals, Inc. received notification from the U.S. Food and Drug Administration of their early action granting accelerated approval of the company's New Drug Application for Beleodaq (belinostat) for Injection for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication was approved by FDA 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 is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations (<250 nM).
Spectrum Pharmaceuticals, Inc. Appoints Deloitte & Touche LLP as the Independent Registered Public Accounting Firm for the Year Ending December 31, 2014
Jun 27 14
Spectrum Pharmaceuticals, Inc. announced that its annual meeting of stockholders held on June 27, 2014 approved the appointment of Deloitte & Touche LLP as the independent registered public accounting firm to audit the company’s financial statements for the year ending December 31, 2014.
Spectrum Pharmaceuticals Completes Enrollment in Phase 2 Trial of SPI-2012
May 28 14
Spectrum Pharmaceuticals announced that the key phase 2 trial of its long-acting granulocyte stimulating factor analog developed using LAPSCOVERY technology (SPI-2012) has completed its Phase 2 study enrollment; this positions Spectrum for Phase 3 decision making before year end. Spectrum's Phase 2 trial is a multicenter, dose-ranging study that evaluates the effectiveness and safety of SPI-2012 relative to a fixed, standard dose of pegfilgrastim as a concurrent active control. The primary objective and endpoint of this study is to assess the effect of SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in patients with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy. Three doses of SPI-2012 were evaluated compared to pegfilgrastim. In January 2012, Spectrum entered into a co-development and commercialization agreement with Hanmi, gaining global rights for SPI-2012 except Korea, China, and Japan.
Spectrum Pharmaceuticals, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 02:30 PM
May 21 14
Spectrum Pharmaceuticals, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 02:30 PM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Rajesh C. Shrotriya, Chairman, Chief Executive Officer, Chairman of Product Acquisition Committee and Chairman of Placement Committee.
Spectrum Pharmaceuticals, Inc. Reports Consolidated Unaudited Earnings Results for the First Quarter Ended March 31, 2014
May 8 14
Spectrum Pharmaceuticals, Inc. reported consolidated unaudited earnings results for the first quarter ended March 31, 2014. For the quarter, the company reported total revenues of $40,124,000 compared with $38,667,000 for the same period last year. Loss from operations was $24,414,000 compared with $6,457,000 for the same period last year. Loss before income taxes was $27,563,000 compared with $7,775,000 for the same period last year. Net loss was $27,641,000 or $0.44 diluted per share compared with $5,435,000 or $0.09 diluted per share for the same period last year. Non-GAAP net income of $0.7 million, or $0.01 per basic and diluted share in the three-month period ended March 31, 2014, compared to a net income of $0.9 million, or $0.01 per basic and diluted share in the comparable period in 2013. Non-GAAP income from operations was $1,969,000 compared with $2,535,000 for the same period last year.