Key Developments: Galena Biopharma Inc (GALE.PH)
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Latest Key Developments (Source: Significant Developments)
Galena Biopharma Inc Acquires Abstral (fentanyl) Sublingual Tablets In U.S From Orexo AB
Galena Biopharma Inc announced that it has entered into an agreement with Orexo AB, an emerging specialty pharmaceutical company based in Sweden, to acquire Abstral (fentanyl) Sublingual Tablets for sale and distribution in the United States. Abstral was approved by the U.S. Food and Drug Administration (FDA) in January 2011. Under the terms of the agreement, Galena Biopharma will pay Orexo $10 million upfront and $5 million within the first twelve months of closing, plus low double digit royalties and one-time payments based on pre-specified net sales. Full Article
Frost & Sullivan Applauds Galena Biopharma Inc For Its Breast Cancer Vaccine, NeuVax
Galena Biopharma Inc announced that based on its recent analysis of the breast cancer vaccines market, Frost & Sullivan recognizes Galena Biopharma, Inc. with the 2013 Global Frost & Sullivan Award for New Product Innovation. The Company's product, NeuVax, has the potential to address a huge unmet medical need for a breast cancer vaccine and provide cost-savings to both patients and governments. NeuVax (nelipepimut-S or E75), a nonapeptide, derived from the human epidermal growth factor receptor 2 (HER2) oncogene, is co-administered with the immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) in an intradermal injection. It is the first breast cancer vaccine to reach Phase III clinical trials and could very well emerge as an off-the-shelf cancer immunotherapy treatment to prevent recurrence. In Phase II studies, NeuVax was shown to prevent or delay breast cancer recurrence in women with early-stage, high-risk (node positive), HER2 low-to-intermediate (immunohistochemical (IHC) 1+/2+ or fluorescent in situ hybridization (FISH) <2.2) disease. NeuVax immunotherapy uses the patient's own immune system to target tumor cells in a highly-specific, less toxic and more-convenient way than conventional cancer therapies. Multiple clinical trials have proven that NeuVax is safe and effective in stimulating cytotoxic (CD8+) T-cells in a highly specific manner to target HER2 expressing cells. Full Article
Galena Biopharma Inc Announces Pricing of Public Offering of Common Stock and Warrants
Galena Biopharma Inc announced the pricing of an underwritten public offering of 15,156,250 units at a public offering price of $1.60 per unit, or total gross proceeds of $24.25 million. Each unit consists of one share of common stock, and a warrant to purchase 0.5 share of common stock at an exercise price of $1.90 per share. The warrants are immediately exercisable and expire on the fifth anniversary of the date of issuance. The shares of common stock and warrants are immediately separable and will be issued separately. The offering is expected to close on December 21, 2012, subject to customary closing conditions. Piper Jaffray & Co. is acting as the sole book-running manager for the offering, with JMP Securities LLC acting as a co-manager. Galena intends to use the net proceeds from the offering to conduct its ongoing Phase 3 clinical trial for NeuVax, its Phase 1/2 clinical trial for Folate Binding Protein-E39 (FBP), the planned Phase 2 clinical trial for NeuVax in combination with trastuzumab (Herceptin), as well as for general corporate purposes. Full Article
Galena Biopharma Inc Announces Public Offering Of Common Stock And Warrants
Galena Biopharma Inc announced that it intends to offer shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Piper Jaffray & Co. is acting as the sole book-running manager for the offering. Galena intends to use the net proceeds from the offering to conduct its ongoing Phase 3 clinical trial for NeuVax, its Phase 1/2 clinical trial for Folate Binding Protein-E39 (FBP), the planned Phase 2 clinical trial for NeuVax in combination with trastuzumab (Herceptin), as well as for general corporate purposes. Full Article
Galena Biopharma Inc Presents Final Landmark 60-Month Results From NeuVax Phase 1/2 Trials
Galena Biopharma Inc presented data from the completed SN-33 Trial and final results from the Phase 1/2 trials of NeuVax (nelipepimut-S or E75) at the 35th Annual CTRC-AACR San Antonio Breast Cancer Symposium. Multiple clinical trials have shown NeuVax to be safe and effective at raising HER2 immunity. Trials SN-33 (NP) (n=97) and SN-34 (NN) (n=90) enrolled clinically eligible patients who were rendered disease-free after completion of standard of care multi-modality therapy (n=187). Treatment assignment was then based on HLA type, with HLA-A2/A3 patients vaccinated and HLA-A2/A3 negative patients followed prospectively as controls for recurrence. NeuVax exhibited safety and tolerability profile, and demonstrated a durable response out to 60 months. The 60-month Landmark Analysis of the SN-33 trial shows that breast cancer recurrence was greatly reduced for patients treated with NeuVax and that these results are both clinically relevant and durable over time. SN-33 Intent-to-treat (ITT) population (n=97); NeuVax (n=53) vs. Control (n=44) 24-month Landmark Analysis 90.6% of NeuVax patients were disease-free versus 79.5% of patients on the control arm. 60-month Analysis: 84.7% of NeuVax patients remain disease-free versus 77.1% of patients on the control arm. Full Article
Galena Biopharma Inc Secures U.S. Patent For NeuVax
Galena Biopharma Inc announced the issuance of a key patent, originally allowed in March 2012, from the U.S. Patent and Trademark Office (USPTO) covering the use of its product candidate, NeuVax, a HER2/neu peptide vaccine, for inducing immunity to breast cancer recurrence in patients having low-to-intermediate IHC levels of 1+ or 2+ and a FISH rating of less than 2.0. Full Article
Galena Biopharma Inc Announces Results From Phase 1/2 Clinical Trial Of NeuVax (E75)
Galena Biopharma Inc announced data from the Phase 1/2 clinical trial of NeuVax (E75). The Phase 1/2 clinical trials evaluated the NeuVax (E75) vaccine, an HLA A2/A3 restricted HER2/neu (HER2) peptide, mixed with GM-CSF. The trials (SN-33 (Node Positive) and SN-34 (Node Negative)) evaluated a combined 187 patients and have completed a median 60-months of follow-up, with the final patients expected to complete their booster treatments and final follow-up visits by September 2012. The final data analysis is expected to be reported in the fourth quarter of this year. Initially, patients in the trials were given a series of up to six inoculations of NeuVax dosed once a month. As the trials progressed, the physicians noticed that E75-specific immunity waned after this initial monthly Primary Vaccine Series (PVS) and translated to late recurrences of cancer in some patients. This declining immunity was identified by monitoring the level of CD8 T-cells in each of the patients. Through this evaluation, it became clear that immunological boosters would keep the level of circulating E75-specific CD8+ T cells elevated during the conduct of the trial. As a result of this finding, a voluntary booster program was added to the trials to maintain long-term immunity following the initial monthly PVS. Full Article
Galena Biopharma Inc Receives Patent
Galena Biopharma Inc announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a Composition of Matter patent covering Folate Binding Peptide (FBP) peptide variants for use either alone or in combination with the FBP vaccine, E39. Full Article
Galena Biopharma Inc Announces Exercise Of Underwriters' Over-Allotment Option And Closing Of $14.5 Million Public Offering Of Common Stock
Galena Biopharma Inc announced that it has closed the previously announced underwritten public offering of 9,751,500 shares of its common stock at a price to the public of $1.50 per share for gross proceeds of approximately $14.5 million. The shares include 1,251,000 shares of common stock sold pursuant to the over-allotment option granted by the Company to the underwriters. The net proceeds from the sale of the shares, after deducting the underwriters' discounts and other estimated offering expenses payable by Galena Biopharma, will be approximately $13.3 million. The Company intends to use the net proceeds of the offering for working capital and other general corporate purposes, including the Phase 3 NeuVax (E75) PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial, Phase 1/2 clinical trials of Folate Binding Protein-E39 (FBP) and a planned Phase 2 trial of NeuVax in combination with Herceptin (trastuzumab; Genentech/Roche). Roth Capital Partners, LLC acted as the sole book-running manager for the offering. Cantor Fitzgerald & Co. and Rodman & Renshaw, LLC acted as co-managers. Full Article
Galena Biopharma Inc Announces Pricing Of Public Offering Of Common Stock
Galena Biopharma Inc announced the pricing of an underwritten public offering of 8,500,000 shares of its common stock at a public offering price of $1.50 per share. The Company has also granted to the underwriters a 30 day option to purchase up to an additional 1,275,000 shares to cover overallotments in connection with the offering. After the underwriting discount and estimated offering expenses payable by the Company, the Company expects to receive net proceeds of approximately $11,600,000, assuming no exercise of the overallotment option. The offering is expected to close on April 11, 2012. Roth Capital Partners, LLC is acting as the sole book running manager for the offering. Cantor Fitzgerald & Co. and Rodman & Renshaw, LLC are acting as co-managers. The company intends to use the net proceeds of the offering for working capital and other general corporate purposes. Full Article
BRIEF-Galena Biopharma jumps in premarket on marketing deal with Teva Pharma
NEW YORK, Dec 4 - Galena Biopharma Inc : * Up 13.7 percent to $2.32 in premarket on marketing deal with Teva Pharmaceutical Industries Ltd
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