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.
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.
Fri, Mar. 13, 9:14 AM
Thu, Mar. 12, 4:06 PM
Fri, Mar. 6, 9:15 AM
Thu, Mar. 5, 4:40 PM
Thu, Mar. 5, 1:37 PM
Wed, Mar. 4, 5:35 PM
Mon, Feb. 9, 9:12 AM
Thu, Jan. 8, 10:46 AM
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%)
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