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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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September 16, 2014
08:02 EDTALNYAlnylam presents ALN-CC5 pre-clinical data
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September 15, 2014
08:01 EDTALNYAlnylam names Karen Anderson as SVP, Chief Human Resources Officer
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07:21 EDTALNYHeart Failure Society of America to hold annual meeting
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September 12, 2014
08:02 EDTALNYAlnylam broadens pipeline with ALN-AGT
Alnylam Pharmaceuticals announced that it is broadening its pipeline with ALN-AGT. In a poster presented at the American Heart Associationís High Blood Pressure Research 2014 Scientific Sessions, Alnylam and collaborators at the Charite Universitatsmedizin in Berlin presented results of an ALN-AGT lead molecule in an established preeclamptic rodent model. The study showed that administration of ALN-AGT resulted in knockdown of maternal AGT in the liver without detectable evidence of fetal drug exposure, significantly improved pregnancy-related hypertension, ameliorated preeclamptic sequelae in the mother such as proteinuria, and improved fetal outcomes.

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