New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 14, 2014
15:26 EDTGALEGalena responds to article by TheStreet.com
Galena Biopharma issued a letter to its shareholders in response to recent media attention stemming from an article by TheStreet.com. "Dear Shareholders: Due to the recent media attention on Galena Biopharma that we acknowledge is having an impact on investor confidence, we felt it necessary, as a service to our shareholders, to publicly respond to the discussions and set the record straight. The genesis of this attention is due to a single reporter, Adam Feuerstein from TheStreet.com, who clearly has an agenda when it comes to Galena. This can be evidenced by his numerous, tabloid-like articles on the company that have appeared over the past three years and are sensational but largely devoid of true information. The article this week is just another in the line, which for us have become noise. Mr. Feuerstein has never requested a meeting with the company to understand the details of our programs or the goals of the company. On the contrary, his requests for information are consistently accusatory and negative. As a result, we do not feel it is worthwhile to engage him or respond to other media outlets that serve to advance his agenda. However, we do recognize that you, our shareholders, deserve a direct response on the matters at hand. The only facts in Mr. Feuerstein's most recent article that are remotely accurate are that Galena previously engaged the DreamTeamGroup and that insiders at the company, including me, divested shares in mid January. All other accusations in this article as with his prior reporting on Galena are specious and conveniently arranged to create controversy."
News For GALE From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use