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May 28, 2014
07:18 EDTDYAXDyax announces dosing of first subject in DX-2930 Phase 1b Trial
Dyax announced dosing of the first subject in its Phase 1b clinical study of DX-2930 in hereditary angioedema patients. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of multiple subcutaneous administrations of DX-2930. Dyax is developing DX-2930 as a subcutaneous injection for prevention of HAE attacks. This Phase 1b trial is a multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of DX-2930 in HAE patients. Approximately 18 subjects will be enrolled into three ascending dose cohorts of DX-2930 or placebo. There will be 4 active drug-treated subjects and 2 placebo-treated subjects per cohort. Each subject will receive two treatments with study drug, separated by two weeks, and undergo approximately 15 weeks of follow-up after the second dose. The company said, "We’ll be utilizing our biomarker assay to assess the possible impact of DX-2930 on exploratory pharmacodynamic parameters such as basal plasma kallikrein activity. We anticipate reporting data from this trial early in 2015.”
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July 29, 2014
16:10 EDTDYAXDyax sees FY14 total revenue $61M-$66M, consensus $58.69M
FY14 estimates include KALBITOR net sales of $51M–$56M. Total top-line revenue guidance excludes royalties from CYRAMZA for which revenue is expected to be recognized, commencing in Q3. Operating costs and expenses are now expected to be in the range of $80M-$82M.
16:07 EDTDYAXDyax reports Q2 EPS (2c), consensus (5c)
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July 23, 2014
08:05 EDTDYAXDyax announces publication of DX-2930 scientific data
Dyax announced the online publication of scientific data for DX-2930 in two peer-reviewed journals. Dyax, a biopharmaceutical company focused on hereditary angioedema (HAE) and other plasma-kallikrein-mediated disorders, is developing DX-2930 as a subcutaneous injection for prevention of HAE attacks. The first paper titled “A Phase 1 Study Investigating DX-2930 in Healthy Subjects” by Chyung et al. was published online in the Annals of Allergy, Asthma and Immunology. These data indicate that DX-2930 has a long half-life in humans and thus the potential for prophylactic inhibition of pKal activity for the therapeutic treatment of HAE. DX-2930 is now being evaluated in a Phase 1b study in patients with HAE. The second paper titled “Inhibition of Plasma Kallikrein by a Highly Specific, Active Site Blocking Antibody” by Kenniston et al. was published online in The Journal of Biological Chemistry. The paper describes the discovery and preclinical evaluation of DX-2930 as a long-acting inhibitor of pKal proteolytic activity. This paper is expected to appear in the September 2014 print issue of the journal. The company said, "These data, combined with data that will be obtained from the ongoing Phase 1b study, will inform and guide the future clinical development of DX-2930.”

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