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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.
News For GALE From The Last 14 Days
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December 11, 2014
08:40 EDTGALEGalena presents HER2 screening data results from NeuVax Phase 3 clinical trial
Galena Biopharma announced that initial immunohistochemistry, or IHC, screening data from 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, trial was presented at the 2014 San Antonio Breast Cancer Symposium, or SABCS. The poster, entitled, "HER2 Discordant Results in Local vs. Central Testing in the Phase 3 Nelipepimut-S Trial and Implementation of Leica Bond Oracle HER2 Immunohistochemistry System for Low and Intermediate Levels of HER2 Protein Expression as a Companion Diagnostic," demonstrated that with the implementation of the Leica Bond Oracle HER2 IHC assay, preliminary limited data indicated additional patients met HER2 eligibility for PRESENT and the assay identified more precisely patients at HER2 1+ and 2+. As part of the PRESENT trial, Galena has implemented central laboratory testing for all potential patients to confirm validated and robust entry criteria, and ensure the enrollment of the targeted patient population. To improve accuracy and specificity for the HER2 1+ and 2+ status testing, and develop a companion diagnostic for NeuVax, the Leica Bond Oracle HER2 IHC system has been incorporated as central HER2 IHC screening for the PRESENT study.
December 8, 2014
09:20 EDTGALEOn The Fly: Pre-market Movers
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07:08 EDTGALEGalena GALE-401 Phase 1 results show reduced platelet counts, tolerable safety
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