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Stock Market & Financial Investment News

News Breaks
July 29, 2014
16:07 EDTDYAXDyax reports Q2 EPS (2c), consensus (5c)
Reports Q2 revenue $19.6M, consensus $14.13M.
News For DYAX From The Last 14 Days
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March 31, 2015
19:38 EDTDYAXOn The Fly: After Hours Movers
HIGHER: Dyax (DYAX), up 47.7% following positive results from Phase 1b clinical trial of DX-2930... Voltari (VLTC), up 93.1% after Carl Icahn reports 52.3% stake... Chesapeake Energy (CHK), up 1.6% after chairman Archie Dunham buys 1M shares of common stock. DOWN AFTER EARNINGS: Cytosorbents (CTSO), down 39.4%... UTi Worldwide (UTIW), down 11.8%... Real Goods Solar (RGSE), down 7%... SYNNEX (SNX), down 3.3%. ALSO LOWER: BioCryst Pharmaceuticals (BCRX), down 8.6% following positive results from Dyax Phase 1b clinical trial of DX-2930... Carpenter Technology (CRS), down 6.4% after targeting a $50M inventory reduction by end of fiscal 2015.
17:47 EDTDYAXDyax continues to advance in after-hours trade, now up 48%
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16:27 EDTDYAXDyax up 32% following positive results from Phase 1b clinical trial of DX-2930
16:04 EDTDYAXDyax receives Fast Track designation from FDA for DX-2930 for HAE
Dyax announced receipt of Fast Track designation from the FDA for the investigation of DX-2930 for HAE.
16:03 EDTDYAXDyax announces positive results deom Phase 1b clinical trial of DX-2930
Dyax announced positive safety, pharmacokinetic, biomarker, and efficacy results from the Phase 1b clinical study of their investigational product, DX-2930. Discovered by Dyax, DX-2930 is a fully human monoclonal antibody inhibitor of plasma kallikrein being developed for the prevention of hereditary angioedema, or HAE, attacks. The ongoing Phase 1b study is a multi-center, randomized, double-blind, placebo-controlled, multiple-ascending dose study designed to assess the safety, tolerability and pharmacokinetics of DX-2930 in HAE patients. An analysis of HAE attack rate was also conducted following a pre-specified statistical analysis plan. A total of 37 subjects were randomized to active drug or placebo in a 2:1 ratio across 4 dosing groups of 30, 100, 300, or 400 mg. Each subject received two doses of DX-2930 or placebo, separated by 14 days, and was followed for 15 weeks after the second dose. DX-2930 was well tolerated at all dose levels. There were no deaths or subject discontinuations due to an adverse event. There were no serious adverse events in subjects treated with DX-2930 and no evidence of dose-limiting toxicity. There was no safety signal in treatment-emergent adverse events, clinical laboratory results, vital signs, or electrocardiograms. Subcutaneous injection was well tolerated. Pharmacokinetic results demonstrated that DX-2930 has linear, dose-dependent exposure and a mean elimination half-life of approximately 14 days across all dose groups studied. Pharmacodynamic results from two different exploratory biomarker assays confirmed ex vivo plasma kallikrein inhibition in a dose- and time-dependent manner. Primary proof-of-concept efficacy analyses were based on subjects in the 300 mg, 400 mg, and placebo dose groups who reported having at least 2 attacks in the 3 months prior to study entry. During the pre-specified, primary efficacy interval of 6 weeks, the HAE attack rate was 0 in the 300 mg group and 0.045 attacks per week in the 400 mg group, compared to 0.37 attacks per week in the placebo group. This resulted in a 100% reduction for the 300 mg dose group as compared to placebo, and an 88% reduction for the 400 mg dose group as compared to placebo. During this primary efficacy interval, 100% of subjects in the 300 mg group and 82% of subjects in the 400 mg group were attack-free compared with 27% of subjects in the placebo group. The study will be complete when all subjects in the 400 mg dose group finish the final safety assessments on study day 120.
13:41 EDTDYAXDyax volatility elevated as shares trade near record high
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