Last $1.53 USD
Change Today +0.04 / 2.68%
Volume 1.3M
As of 8:10 PM 12/26/14 All times are local (Market data is delayed by at least 15 minutes).

galena biopharma inc (GALE) Snapshot

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$1.50
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$1.49
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52 Week High
01/14/14 - $7.77
52 Week Low
12/23/14 - $1.48
Market Cap
187.9M
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1.4M
EPS TTM
$-0.71
Shares Outstanding
122.8M
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Current Stock Chart for GALENA BIOPHARMA INC (GALE)

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galena biopharma inc (GALE) Details

Galena Biopharma, Inc., a biopharmaceutical company, focuses on developing and commercializing oncology treatments that address major unmet medical needs to advance cancer care. Its commercial product includes Abstral, a sublingual tablet, which is used as treatment option for breakthrough cancer pain in patients. The company’s lead product candidate comprise NeuVax (nelipepimut-S or E75), which has completed Phase III clinical trials for preventing the recurrence of breast cancer; and Phase IIb clinical trials in combination with Herceptin for the treatment of breast cancer. It also develops GALE-301 or Folate Binding Protein (FBP), a therapeutic target that has completed Phase II clinical trials for the treatment of ovarian and endometrial cancers; and GALE-401 (Anagrelide CR), which has completed Phase I studies for the treatment of essential thrombocythemia. Galena Biopharma, Inc. has strategic partnership with Dr. Reddy's Laboratories Ltd. 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 Lake Portland, Oregon.

60 Employees
Last Reported Date: 03/17/14
Founded in 2003

galena biopharma inc (GALE) Top Compensated Officers

Chief Executive Officer and President
Total Annual Compensation: $490.0K
Chief Financial Officer, Vice President and C...
Total Annual Compensation: $236.0K
Compensation as of Fiscal Year 2013.

galena biopharma inc (GALE) Key Developments

Galena Biopharma, Inc. Announces Initial Immunohistochemistry (Ihc) Screening Data from the NeuVax

Galena Biopharma, Inc. announced that initial immunohistochemistry (IHC) screening data from the NeuVax (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) trial was presented at the 2014 San Antonio Breast Cancer Symposium (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 (IHC) System for Low and Intermediate Levels (1+, 2+) 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 Oracleâ„¢ HER2 IHC system has been incorporated as central HER2 IHC screening for the PRESENT study.

Galena Biopharma, Inc. Announces Phase 1 of GALE-401 (Anagrelide Controlled) Clinical Trial Data at the 56th American Society of Hematology Annual Meeting & Exposition

Galena Biopharma, Inc. announced that data from the company's phase 1 clinical trials of GALE-401, or Anagrelide Controlled Release (CR), were presented at the 56th American Society of Hematology (ASH) Annual Meeting & Exposition. The poster presentation also included preliminary data from the ongoing GALE-401 Phase 2 clinical trial in patients with elevated platelet counts due to myeloproliferative neoplasms (MPN's). GALE-401 Phase 1 Clinical Trials: The poster entitled, 'phase 1 study results of a Novel Controlled-Release Formulation of Anagrelide (GALE-401) for the Treatment of Thrombocytosis," showed that GALE-401 (Anagrelide CR) is a promising, novel formulation of anagrelide. The Phase 1 trials demonstrated that GALE-401 possesses a pharmacokinetic (PK) profile of a significantly reduced Cmax, or time to maximum plasma concentration, while maintaining adequate plasma exposure needed to induce platelet count reductions in the healthy subjects. Dose-related reductions in platelet counts were observed, and were similar to the marketed immediate release (IR) formulation of anagrelide in a cross-over, multiple dose study. The product was well tolerated with an adverse event (AE) profile that was not distinguishable from placebo. The Phase 1 trials included 5 studies that enrolled a total of 98 healthy adult subjects, including 12 placebo-control subjects and 86 subjects who received single or multiple doses of Anagrelide CR ranging from 0.2 to 0.6 mg twice daily (b.i.d.) for up to 41 days. The trials included an open-label, single dose developmental study to select a formulation; two placebo-controlled multiple dose ranging studies; a food effect study; and a comparative crossover PK study vs. IR reference product. Safety assessments included laboratory, electrocardiograms (ECGs), and clinical evaluations. Single doses of Anagrelide CR were well tolerated, and the only drug- related AE reported in two or more subjects was headache. In the b.i.d. dose-ranging studies, the frequency and severity of AEs were similar between Anagrelide CR and placebo groups, with the exception of decreased platelet counts in subjects receiving Anagrelide CR. All AEs were transient, mild or moderate in severity, and no severe or serious AEs were reported. GALE-401 demonstrated dose proportional PK characteristics, and plasma exposure was higher when CR was administered in the fed versus fasted state. In a placebo-controlled study of 0.2 to 0.6 mg b.i.d. dosing for up to 21 days (n=8 subjects/cohort randomized 2:1 to anagrelide or placebo), a dose-related decrease in platelet counts was observed, and the 0.6 mg cohort was halted early due to excessive platelet reductions. In a cross-over, multiple dose study of Anagrelide CR and IR (0.5mg b.i.d., N=20 subjects), similar reductions in platelet counts were observed despite differences in PK exposure. GALE-401 Phase 2 Preliminary Results: The GALE-401 Phase 2 clinical proof-of-concept study is an open-label, single-arm, multicenter study in patients with an MPN-related thrombocytosis. The primary objective is to estimate the response rate in terms of platelet reduction, and the trial will also assess safety and tolerability, and measure plasma concentrations of anagrelide. The platelet lowering ability of GALE-401 will be measured by the proportion of patients that achieve a complete platelet response (CR = =400 x 109/L) or partial platelet response (PR = =600 x 109/L or a =50% reduction from baseline) maintained for at least four weeks during 24 weeks of treatment. With enrollment complete, patients are being followed for platelet response while they continue study treatment. Safety is assessed by frequency and severity of AEs. The poster also presented preliminary results for the Phase 2 trial, which enrolled 18 subjects with the following MPNs: 13 Essential Thrombocythemia, 4 Polycythemia Vera, 1 Primary Myelofibrosis. Patients were previously treated with hydroxyurea (n=8), Anagrelide IR (n=6), None (n=7), and were washed out of any prior therapies and their baseline platelet counts were returned to =600 x 109/L before treatment with Anagrelide CR.

Galena Biopharma to Present HER2 Screening Data from the Phase 3 NeuVax(TM) (nelipepimut-S) Clinical Trial

Galena Biopharma, Inc. announced that initial immunohistochemistry (IHC) screening data from the NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial will be presented at the 2014 San Antonio Breast Cancer Symposium (SABCS). The IHC screening data identifies IHC HER2 1+ and 2+ patients to support the PRESENT study and a companion diagnostic for NeuVax. Poster #P2-15-02 (Abstract #1394) is entitled, "HER2 Discordant Results in Local vs. Central Testing in the Phase 3 Nelipepimut-S Trial and Implementation of Leica Bond Oracle HER2 Immunohistochemistry (IHC) System for Low and Intermediate Levels (1+, 2+) of HER2 Protein Expression as a Companion Diagnostic," and will be presented during Poster Session 2 on December 11, 2014, from 7:30 - 9:00 a.m. in Exhibit Halls A-B. NeuVax(TM) (nelipepimut-S) is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA).

 

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