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August 7, 2014
06:13 EDTAZN, DVAXDynavax says AZD1419 Phase 1 study met secondary endpoints
In a Phase 1 study, 4 weekly doses of a TLR9 agonist, AZD1419, or placebo were delivered by inhalation to 45 healthy volunteers. Ascending doses up to 15.4 mg/week for 4 weeks were well tolerated and no serious adverse events were observed in treated subjects. Secondary endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells. Based on these results, Dynavax (DVAX) and its collaboration partner, AstraZeneca (AZN), are evaluating protocols for a clinical trial in patients with asthma.
News For DVAX;AZN From The Last 14 Days
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July 28, 2015
07:20 EDTAZNBrookings Institute to hold a public meeting
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July 27, 2015
05:25 EDTAZNGenzyme acquires Caprelsa from AstraZeneca for $300M
Genzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.
July 22, 2015
13:58 EDTAZNPiper cuts Array target by only 50c after failed trial
Piper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.
09:07 EDTAZNOn The Fly: Pre-market Movers
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08:17 EDTDVAXDynavax 4.55M share Spot Secondary priced at $27.50
Cowen, RBC Capital and William Blair acted as joint book running managers for the offering.
05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
July 21, 2015
16:02 EDTDVAXDynavax files to sell common stock, no amount given
Dynavax anticipates using the net proceeds from the proposed offering to fund activities associated with completing the ongoing Phase 3 HBV-23 study of HEPLISAV-B(TM), seeking regulatory approval of HEPLISAV-B in the United States, and preparing for the anticipated U.S. commercial launch of HEPLISAV-B, should HEPLISAV-B gain approval by the Food and Drug Administration. In addition, net proceeds from the offering will support continuing the clinical development of our investigational cancer immunotherapeutic product candidate, SD-101, and for other general corporate purposes, including working capital. Cowen and Company, RBC Capital Markets and William Blair are acting as joint book-running managers for the offering.
July 15, 2015
17:00 EDTAZNInnerWorkings to provide AstraZeneca exclusive marketing execution
InnerWorkings (INWK), the leading marketing execution firm, has become the exclusive North American marketing execution partner of AstraZeneca (AZN). Under the seven-year agreement, InnerWorkings will manage AstraZeneca’s marketing print operations across North America, which will improve AstraZeneca’s transparency and reporting as well as strengthen its brand impact. Strategically placed across the U.S., InnerWorkings’ three onsite teams based in Delaware, Maryland, and Pennsylvania will help AstraZeneca sharpen its financial visibility, unify its brands, and enhance its marketing effectiveness. By tapping InnerWorkings’ $1B-dollar buying power, AstraZeneca will gain vital insights, promote sustainability, and refine its marketing spend.

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