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Last $1.60 USD
Change Today +0.18 / 12.68%
Volume 6.9M
GALE On Other Exchanges
As of 10:51 AM 05/27/15 All times are local (Market data is delayed by at least 15 minutes).

galena biopharma inc (GALE) Snapshot

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06/11/14 - $3.58
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galena biopharma inc (GALE) Details

Galena Biopharma, Inc., a biopharmaceutical company, focuses on developing and commercializing oncology therapeutics that address major unmet medical needs across cancer care. Its commercial products include Abstral, a sublingual tablet that is used for the management of breakthrough pain in patients with cancer; and Zuplenz, an oral soluble film for use in the prevention of emetogenic chemotherapy-induced, radiotherapy-induced, and post-operative nausea and vomiting. The company’s lead product candidate comprise NeuVax (nelipepimut-S), which is in Phase III clinical trials for use in the prevention of recurrence in early- stage and node-positive breast cancer with low to intermediate human epidermal growth factor receptor (HER2) expression; Phase IIb clinical trials in combination with Herceptin that is used for HER2 1+/2+ node-positive and high-risk node-negative breast cancer treatment; and Phase II clinical trials in combination with Herceptin for use in HER2 gene-amplified breast cancer treatment. It also develops GALE-301 (folate binding protein), which is in Phase IIa clinical trials that is used for the prevention of recurrence in patients with ovarian and endometrial cancers; and GALE-401 (anagrelide controlled release), which has completed Phase I clinical trials that is used for the treatment of patients with myeloproliferative neoplasms to lower elevated platelet levels. Galena Biopharma, Inc. has strategic development and commercialization partnership with Dr. Reddy's Laboratories Ltd. for NeuVax in breast and gastric cancers. The company was formerly known as RXi Pharmaceuticals Corporation and changed its name to Galena Biopharma, Inc. in September 2011. Galena Biopharma, Inc. was founded in 2003 and is based in Portland, Oregon.

57 Employees
Last Reported Date: 03/5/15
Founded in 2003

galena biopharma inc (GALE) Top Compensated Officers

Chief Executive Officer, President, Director ...
Total Annual Compensation: $707.1K
Chief Financial Officer and Vice President
Total Annual Compensation: $299.4K
Vice President, General Counsel and Corporate...
Total Annual Compensation: $145.5K
Compensation as of Fiscal Year 2014.

galena biopharma inc (GALE) Key Developments

Galena Biopharma, Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Reiterates Revenue Guidance for the Fiscal 2015; Announces Complete the Enrollment in the NeuVax Phase 3 PRESENT Breast Cancer Immunotherapy Clinical Trial

Galena Biopharma, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the first quarter of 2015, net loss was $10.54 million, or $0.08 per basic and diluted share, compared to a net loss of $2.54 million, or $0.02 per basic and diluted share, for the first quarter of 2014. Net revenue was $2.75 million against $2.17 million a year ago. Operating loss was $11.13 million against $11.85 million a year ago. The decrease in net operating loss year-over-year is primarily the result of the completion of enrollment in Phase 3 PRESENT trial for NeuVax, as well as the decrease in stock based compensation. Full year 2015 net revenue guidance reiterated at $15-$18 million. The company announced NeuVax™ (nelipepimut-S) achieves critical milestone with completion of over-enrollment in its Phase 3 PRESENT (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 cancer recurrence after standard of care treatment in the adjuvant setting in breast and gastric cancers. Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat (ITT) population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment (SPA), called for 700 patients; and, the Company expects this higher number of ITT patients will increase the confidence in the timing, 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 follow-up, or a total of 141 events (recurrence or death) occur, whichever comes later. PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and is being conducted in 13 countries at more than 140 sites. Expanded the patient population in the Phase 2 clinical trial with NeuVax in combination with trastuzumab in HER2 1+/2+ patients to include Human Leukocyte Antigen (HLA) A24 or A26 Positive Patients.  The trial evaluates node positive, triple negative, and high-risk node negative breast cancer patients with immunohistochemistry (IHC) HER2 1+/2+ expressing tumors who are disease-free after standard of care therapy. To date, NeuVax has been tested in trials with patients who are HLA-A2+ or A3+, representing more than 60% of the North American, European and Chinese populations. NeuVax has also been shown to bind to HLA-A24 and A26, which represents an additional 10-15% of the population in the U.S., but more importantly, represents up to approximately 70% of the population in Japan.

Galena Biopharma, Inc. to Report Q1, 2015 Results on May 07, 2015

Galena Biopharma, Inc. announced that they will report Q1, 2015 results at 5:00 PM, Eastern Standard Time on May 07, 2015

Galena Biopharma, Inc., Q1 2015 Earnings Call, May 07, 2015

Galena Biopharma, Inc., Q1 2015 Earnings Call, May 07, 2015


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