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Stock Market & Financial Investment News

News Breaks
July 22, 2014
09:55 EDTGALEGalena 'stands little chance' of improving Zuplenz sales, TheStreet says
After Galena BioPharma entered into a license agreement with MonoSol Rx for Zuplenz, TheStreet's Adam Feuerstein predicted that the company "stands little chance of delivering higher sales of Zuplenz than its previous marketer," calling the drug one that "no one wants" and "something to promote while waiting for the phase III study of NeuVax in breast cancer to inevitably fail." Reference Link
News For GALE From The Last 14 Days
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April 21, 2015
09:34 EDTGALEGalena sent FDA warning letter following site inspection
A warning letter published by the FDA, dated April 3, states that the agency's inspection of Galena Biopharma's site in Portland, Oregon, conducted between November 17 and 21, 2014, revealed "serious violations" of FDAs PADE reporting requirements. Reference Link
April 14, 2015
07:26 EDTGALEGalena completes over-enrollment of NeuVax Phase 3 PRESENT clinical trial
Galena Biopharma announced the completion of enrollment in the NeuVax Phase 3 PRESENT, or Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, clinical trial. NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat, or ITT, population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment, or SPA, called for 700 patients; and, the company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events occur, whichever comes later.

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