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April 2, 2014
08:08 EDTALNYAlnylam receives positive opinion for orphan drug designation ALN-TTRsc
Alnylam Pharmaceuticals announces that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product for the treatment of transthyretin-mediated amyloidosis. ALN-TTRsc is currently in a pilot Phase 2 clinical trial for the treatment of ATTR patients with TTR cardiac amyloidosis; this study is aimed at evaluating the tolerability of ALN-TTRsc in approximately 15 patients. In addition, the study will assess preliminary clinical activity as measured by knockdown of serum TTR levels and additional exploratory tests, such as cardiac imaging, circulating cardiac biomarkers, 6-minute walk test, New York Heart Association classification, and measures of heart failure symptoms and quality of life. The company expects to present data from the Phase 2 trial in late 2014. Patients completing the Phase 2 trial will be eligible to participate in an open-label extension study for further assessment of general tolerability and clinical activity with long-term dosing; the ALN-TTRsc Phase 2 OLE study is expected to be initiated in mid-2014. Assuming positive results, Alnylam expects to begin a Phase 3 trial in TTR cardiac amyloidosis patients by the end of 2014.
News For ALNY From The Last 14 Days
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March 4, 2015
10:01 EDTALNYOn The Fly: Analyst Initiation Summary
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07:10 EDTALNYCowen to hold a conference
35th Annual Health Care Conference is being held in Boston on March 2-4 with webcasted company presentations to begin on March 4 at 8 am; not all company presentations may be webcasted. Webcast Link
05:37 EDTALNYAlnylam initiated with an Overweight at Barclays
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February 27, 2015
09:58 EDTALNYOn The Fly: Analyst Initiation Summary
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06:59 EDTALNYAlnylam initiated with an Outperform at Cowen
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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.

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