Thu, Aug. 6, 4:20 PM
Wed, Aug. 5, 5:35 PM
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Thu, Jul. 30, 9:52 AM
- Tesaro (TSRO -3.8%) secures an exclusive license agreement with China-based Jiangsu Hengrui Medicine Co. for the development, registration, manufacture and commercialization of rolapitant in China. Specific financial terms are not disclosed.
- Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist under development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The company's NDA is currently under FDA review with a PDUFA date of September 5.
- CINV-related tickers: (GALE -1.8%)(HRTX -2.2%)(MRK -0.1%)(RDHL -0.1%) (OTC:ESALF) (OTCPK:ESALY) (OPK -1.3%)(INSY -2.3%)(GWPH -2.1%)
Wed, Jul. 29, 9:53 AM
- Galena Biopharma (GALE +5%) announces the U.S. launch of Zuplenz (ondansetron) Oral Soluble Film in 4 mg and 8 mg strengths. It is indicated for prevention of chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting and post-operative nausea and vomiting in adult patients. It is also cleared for moderately emetogenic CINV in pediatric patients at least four years old.
- Zuplenz, based on an oral soluble film technology called PharmFilm, dissolves in the mouth in about 10 seconds. It does not require water to administer and enables the patient to avoid the burden of swallowing a pill.
Mon, Jun. 15, 12:41 PM
- Interim data from a Phase 2 trial assessing Galena Biopharma's (GALE) anagrelide controlled release (GALE-401) in patients with thrombocytosis secondary to essential thrombocythemia (ET) and other myeloproliferative neoplasms (MPNs) show encouraging efficacy. The data were presented at the 20th Congress of the European Hematology Association in Vienna, Austria.
- The overall response rate in the 18-subject study was 78% (n=14/18) and complete and partial response rates were both 39% (n=7/18). The median time to response was five weeks (range: 3-10) while the median duration of response had not been reached by the data cutoff.
- Thrombocytosis is a disorder in which the body produces too many platelets.
- The immediate release formulation of anagrelide, Agrylin, was approved in 1997 for the indication.
- Final data from the trial will be presented at the American Society of Hematology meeting in December.
Mon, Jun. 8, 9:16 AM
Wed, May 27, 1:19 PM
- Galena Biopharma (GALE +12%) heads north on a 4x surge in volume in apparent response to the publication of two abstracts at ASCO.
- The first, Abstract #e14031, is a summary of results from a 51-subject Phase 1/2a dose-ranging study of GALE-301 (folate binding protein), a peptide immunotherapy given as an adjuvant treatment to prevent recurrences in high-risk ovarian and endometrial cancer patients. With almost 10 months median followup, the 1000 mcg dose group showed only one clinical recurrence compared to 11 in the control group. The estimate for disease-free survival at two years is 85.7% for the 1000 mcg cohort versus 19.2% for control but the results are not statistically significant (p=0.09). Combining the low dose group (<1000 mcg) dropped the complete response rate to 38% versus 50% for control although, again, the results lacked statistical validity (p=0.41). These data were presented in November at the Society for Immunotherapy of Cancer meeting in Maryland.
- The second, Abstract #e11609, is a summary of data supporting the use of the BOND Oracle HER2 IHC System for identifying low-to-medium HER2-expressing breast cancer patients that would be candidates to receive NeuVax (nelipepimut-S).
Wed, May 27, 9:18 AM
Fri, May 8, 6:14 AM
- Galena Biopharma (GALE +1.5%) Q1 results: Revenues: $2.8M (+27.3%); COGS: $0.4M (+33.3%); R&D Expense: $5.9M (-13.2%); SG&A: $7.4M (+8.8%); Operating Loss: ($11.1M) (+5.9%); Net Loss: ($10.5M) (-320.0%); Loss Per Share: ($0.08) (-300.0%); Quick Assets: $52.9M (+123.2%).
- 2015 Guidance: Abstral Revenue: $15M - 18M.
Thu, May 7, 4:22 PM
Wed, May 6, 5:35 PM
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Tue, Apr. 14, 7:46 AM
- Galena Biopharma (NASDAQ:GALE) reports that it has enrolled 758 patients in its Phase 3 PRESENT trial assessing its immunotherapy NeuVax (nelipepimut-S) to prevent breast cancer recurrence after standard-of-care treatment in the adjuvant setting. The protocol specifies 700 patients, but the company recruited more in order to increase the confidence in the statistics. It expects to reach the primary endpoint in 2018, after the later of the last patient dosed reaching her 36th month of treatment or a total of 141 events occur (death or recurrence).
- The randomized, double-blind, placebo-controlled trial is being run in 13 countries at more than 140 sites. Enrolled patients must be lymph node positive, HLA A2 or A3 positive and have Stage IIa - IIIa breast cancer. Once they complete the current standard-of-care treatment, they are administered an injection of NeuVax once per month for six months, then five booster injections once every six months. There are currently no treatment options for these patients to maintain their disease-free status.
Fri, Apr. 10, 12:38 PM
- Galena Biopharma (GALE -4.2%) reports that the underwriters over-allotment of 3,653,846 shares of common stock that was part of its public offering of 24.4M units has been fully exercised at a price of $1.457 per share. Additional net proceeds were ~$5.4M which increased the total net to ~$40.8M.
- The money will fund operations, working capital, clinical trials and general corporate purposes.
- Previously: Galena prices equity offering (March 13)
Fri, Apr. 10, 9:12 AM
Fri, Apr. 10, 6:56 AM
- Galena Biopharma (NASDAQ:GALE) receives a Warning Letter from the FDA citing deficiencies in its December 11, 2014 response letter to its Form 483 observations following an inspection of its Portland, Oregon facility in November 2014. The deficiencies pertain to the company's written procedures for the surveillance, receipt, evaluation and reporting of post-marketing adverse drug experiences from all sources and the failure to report each adverse drug experience not cited in its mandated quarterly report [CFR 314.80(c)(1)(i)].
- Per FDA regulations, the company must submit a written response to the Warning Letter within 15 days. There should not be a disruption in its commercial operations, but if the issues cannot be resolved to the agency's satisfaction, future filings could be delayed until the deficiencies are resolved.
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.
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