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News Breaks
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 Alnylams 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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December 18, 2014
08:09 EDTALNYAlnylam names Cubist CEO Michael Bonney to board of directors
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December 15, 2014
08:42 EDTALNYAlnylam price target raised to $125 from $105 at Leerink
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06:06 EDTALNYAlnylam price target raised to $158 from $134 at Piper Jaffray
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December 12, 2014
10:01 EDTALNYOn The Fly: Analyst Initiation Summary
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07:05 EDTALNYAlnylam sees filing IND for ALN-HBV DC program in late 2015
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07:03 EDTALNYAlnylam sees initial data from ALN-PCSsc trial in mid-2015
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07:02 EDTALNYAlnylam updates guidance to file clinical trial application for ALN-AS1
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05:30 EDTALNYAlnylam initiated with a Neutral at Goldman
Goldman started shares of Alnylam Pharmaceuticals with a Neutral rating and $113 price target saying it prefers to wait for a more favorable entry point into the name.
December 11, 2014
16:02 EDTALNYAlnylam initiates ENDEAVOUR Phase 3 clinical trial with revusiran
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08:02 EDTALNYAlnylam, The Medicines Co. announce initiation of Phase 1 ALN-PCSsc trial
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December 9, 2014
12:22 EDTALNYPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
06:38 EDTALNYAlnylam to host conference call
Conference call to discuss Phase 1 data from ALN-AT3, in development for the treatment of hemophilia will be held on December 9 at 8 am. Webcast Link
05:47 EDTALNYAlnylam reports poisitve initial results for ALN-AT3
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December 7, 2014
13:13 EDTALNYAlnylam files clinical trial application for ALN-CC5
Alnylam Pharmaceuticals announced that it has filed a Clinical Trial Application, CTA, with the U.K. Medicines and Healthcare products Regulatory Agency, MHRA, to initiate a Phase 1/2 clinical trial with ALN-CC5, a subcutaneously administered investigational RNAi therapeutic targeting complement component C5 for the treatment of complement-mediated diseases. As per the CTA filing, the intended clinical study of ALN-CC5 will be performed in normal human volunteers and, then, in patients with paroxysmal nocturnal hemoglobinuria, PNH. Following approval of the CTA, the company expects to initiate the Phase 1/2 study in early 2015, with initial data expected to be reported in mid-2015. In addition, Alnylam scientists presented new pre-clinical data at the 56th Annual Meeting of the American Society of Hematology. Amongst other reported research findings, new data showed an up to 99.2% knockdown of serum C5 and up to 96.2% inhibition of serum hemolytic activity in non-human primates, NHPs, with continued dosing for over seven months.
December 5, 2014
08:39 EDTALNYAlnylam to host research and development day
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