Thu, Mar. 26, 11:55 AM
- Galena Biopharma (GALE -2.5%) announces that women who are human leukocyte antigen (HLA)-A24+ or HLA-A26+ are now eligible for enrollment in its ongoing Phase 2b study evaluating NeuVax (nelipepimut-S), in combination with trastuzumab (Herceptin), in breast cancer patients who are node positive and triple negative and those who are node negative with HER 1+/2+ expressing tumors who are disease-free after standard-of-care therapy. HLA-A24- and/or A26-positive patients are predominantly of Asian descent.
- HLA-A2+ or A3+ women represent more than 60% of the North American, European and Chinese breast cancer populations. HLA-A24+ and A26+ patients represent an additional 10 - 15% in the U.S., but up to 70% of the breast cancer population in Japan.
- The primary efficacy endpoint of the study is invasive disease-free survival through Year 5. The trial began in October 2014 and will run until October 2019, although the final data collection for measuring the primary endpoint will happen in October 2016.
- NeuVax is an HER2-directed immunotherapy being investigated for the prevention of breast cancer recurrence after standard-of-care treatment in the adjuvant setting. Adjuvant therapy is any treatment given after primary (first-line) therapy.
Fri, Mar. 13, 12:45 PM
Fri, Mar. 13, 9:31 AM
- Galena Biopharma (GALE -17.3%) prices its public offering of 24,358,974 units at $1.56 per unit. Each unit consists of one share of common stock and a warrant to purchase one half of a share of common stock at an exercise price of $2.08. Underwriters over-allotment is an additional 3,653,846 shares of stock and warrants to purchase up to 1,826,923 shares. Closing date is March 18.
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Dec. 9, 2014, 12:38 PM
- RedHill Biopharma Ltd. (RDHL +12.2%) submits a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency and several other member states seeking approval for the 5-HT3 receptor Bekinda (ondansetron) (formerly RHB-102) for the treatment of cancer therapy-induced nausea and vomiting.
- The MAA has been submitted under the European Mutual Recognition Procedure with the UK as the reference European member state.
- The 5-HT3 market is estimated at ~$940M worldwide with Europe representing ~1/3 of the total.
- CINV-related tickers: (OTC:ESALF) (OTCPK:ESALY -3%) (OPK +1.1%)(GALE +1.8%)(INSY +0.7%)(HRTX +1.3%)(TSRO +2.9%)(GWPH +4.5%)
Nov. 24, 2014, 12:46 PM
Nov. 18, 2014, 1:34 PM
- Galena Biopharma (GALE +3.6%) completes the enrollment of 18 patients six months ahead of schedule in a Phase 2 proof-of-concept trial to assess the platelet lowering ability of GALE-401 (anagrelide controlled release) in patients with myeloproliferative neoplasms.
- The platelet lowering effect will be measured by the proportion of patients that achieve a complete or partial response for at least four weeks during the 24-week treatment cycle.
- GALE-401 is the company's new formulation of anagrelide. It releases its active ingredient more slowly over time than currently marketed versions of the drug.
Nov. 11, 2014, 12:04 PM
- Galena Biopharma (GALE +0.5%) reports that the first patient has been dosed in a new Phase 2 study evaluating NeuVax (nelipepimut-S) in combination with Roche's Herceptin (trastuzumab) for the prevention of breast cancer recurrence in high risk HER2 3+ and/or HER2 gene-amplified patients. Trial participants will be defined as 3+ by immunohistochemistry or gene amplified on the basis of being HER2 2+ and/or fluorescence in situ hybridization (FISH) >2.0.
- Patients will be randomized to receive NeuVax + GM-CSF (granulocyte macrophage-colony stimulating factor) + Herceptin or Herceptin + GM-CSF alone in the adjuvant setting following surgery.
- The primary endpoint in invasive disease-free survival. The company expects to complete the enrollment of 100 patients by 2H 2016. The follow-up period will be three years.
Nov. 3, 2014, 4:42 PM
- Galena Biopharma (GALE -6.8%) Q3 results ($M): Revenues: 1.6 (+38.5%); Costs and Expenses: 14.8 (+83.9%); Operating Loss: (13.2) (-91.6%); Net Loss: (6.2) (+33.5%); Loss Per Share: (0.05) (+54.5%); Quick Assets: 24.6 (-48.4%).
- NeuVax Phase 3 Present trial status: 533 of 700 patients treated.
- 2014 Guidance: Abstral revenue: $8M - 10M.
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