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May 13, 2014
08:01 EDTALNYAlnylam announces results from ongoing phase 1 trial of ALN-AT3
Alnylam Pharmaceuticals announced top-line results from its ongoing Phase 1 trial of ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin in development for the treatment of hemophilia and rare bleeding disorders. These top-line results are being presented at the World Federation of Hemophilia 2014 World Congress being held May 11 – 15, 2014 in Melbourne, Australia. In Part A of the Phase 1 study, human volunteer subjects received a single subcutaneous dose of ALN-AT3 and, per protocol, the maximum allowable level of AT knockdown was set at 40%. Initial results show that a single, low subcutaneous dose of ALN-AT3 at 0.03 mg/kg resulted in an up to 28-32% knockdown of AT at nadir that was statistically significant relative to placebo. This led to a statistically significant increase in peak thrombin generation, that was temporally associated and consistent with the degree of AT knockdown. ALN-AT3 was found to be well tolerated with no significant adverse events reported. With these data, the company has transitioned to the Multiple Ascending Dose Part B of the study in moderate-to-severe hemophilia subjects. Consistent with previous guidance, the company plans to present initial clinical results from the Phase 1 study, including results in hemophilia subjects, by the end of the year. These human study results are the first to be reported for Alnylam’s Enhanced Stabilization Chemistry-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency, durability, and a wide therapeutic index. Further, these initial clinical results demonstrate a greater than 50-fold potency improvement with ESC-GalNAc conjugates relative to standard template chemistry conjugates.
News For ALNY From The Last 14 Days
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February 23, 2015
07:22 EDTALNYSunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.
February 12, 2015
18:52 EDTALNYOn The Fly: After Hours Movers
UP AFTER EARNINGS: Cyberark Software (CYBR), up 16.3%... Ellie Mae (ELLI), up 14%... Rocky Brands (RCKY), up 11.7%... Mattson Technology (MTSN), up 11.7%... J2 Global (JCOM), up 9.2%... New Relic (NEWR), up 4.3%... Columbia Sportswear (COLM), up 5.5%... Alnylam Pharmaceuticals (ALNY), up 3.1%... CBS (CBS), up 3.3%... LogMeIn (LOGM), up 1.1%. DOWN AFTER EARNINGS: Knowles (KN), down 13.1%... Zynga (ZNGA), down 12.8%... Mobileiron (MOBL), down 1.4%... Shutterfly (SFLY), down 4.2%... Groupon (GRPN), down 1.1%. ALSO LOWER: Magnachip (MX), down 40.1% after restating financial results... Campbell Soup (CPB), down 4.2% after issuing profit and sales warning.
16:09 EDTALNYAlnylam up 5.6% after reporting Q4 results
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16:08 EDTALNYAlnylam reports Q4 EPS (28c), consensus (60c)
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15:41 EDTALNYNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include AIG (AIG), consensus $1.05... Liberty Global (LBTYA), consensus 8c... Kraft (KRFT), consensus 73c... CBS (CBS), consensus 76c... DaVita HealthCare (DVA), consensus 89c... Republic Services (RSG), consensus 48c... Assurant (AIZ), consensus $1.66... Alnylam Pharmaceuticals (ALNY), consensus (60c)... American Equity (AEL), consensus 54c... Boyd Gaming (BYD), consensus (4c)... Regal Entertainment (RGC), consensus 29c... King Digital (KING), consensus 47c... Ironwood Pharmaceuticals (IRWD), consensus (21c)... Groupon (GRPN), consensus 3c... Zynga (ZNGA), consensus 0c... SS&C Technologies (SSNC), consensus 62c... Cognex (CGNX), consensus 26c... Taubman Centers (TCO), consensus 74c... j2 Global (JCOM), consensus 90c.

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