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News Breaks
January 13, 2014
07:07 EDTGALEGalena acquires Mills Pharmaceuticals in share transaction
Galena Biopharma announced it has acquired Mills Pharmaceuticals, which has the worldwide rights to GALE-401, a patented, controlled release formulation of anagrelide. Galena expects to pursue the expedited 505(b)(2) regulatory pathway to seek approval of GALE-401 for the treatment of Essential Thrombocythemia, or ET. The company also believes GALE-401 meets the qualifications for orphan drug status. GALE-401 has an estimated peak market size of approximately $200M in the U.S. Under the terms of the agreement, Galena paid an up-front payment to Mills Pharmaceuticals' owners. Additionally, Mills Pharmaceuticals owners are eligible to receive one-time payments of up to 4M shares with the achievement of specified regulatory milestones. The owners of Mills Pharmaceuticals are also eligible to receive $3M upon FDA approval of a new drug application in respect to GALE-401. GALE-401 possesses a broad patent portfolio and provides intellectual property protection through at least 2029. Mills Pharmaceuticals is affiliated with Aceras Partners. Roth Capital Partners acted as financial advisor to Galena in this transaction.
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August 24, 2015
07:07 EDTGALEIDMC recommends reduction of cardiac toxicity monitoring in Galena NeuVax trial
Galena Biopharma announced that the Independent Data Monitoring Committee, or IDMC, has recommended to the company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax Phase 3 Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, or PRESENT, clinical trial. The trial is being run under a Special Protocol Assessment, or SPA, approved by the FDA. Following its most recent IDMC meeting in June, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram, or ECHO, or multiple-gated acquisition, or MUGA, scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.

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