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March 18, 2013
08:05 EDTALNYAlnylam initiates phase I study for subcutaneously delivered RNAi therapeutic
Alnylam Pharmaceuticals announced that it has initiated dosing in its Phase I clinical trial with ALN-TTRsc, an RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis. The Phase I trial of ALN-TTRsc is being conducted in the U.K. as a randomized, double-blind, placebo-controlled, single- and multi-dose, dose-escalation study, enrolling up to 40 healthy volunteer subjects. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of subcutaneously administered ALN-TTRsc. Secondary objectives include assessment of clinical activity of the drug as measured by serum TTR levels. Alnylam expects to present data from this trial in mid-2013. Upon completion of the Phase I trial, the company plans to start a Phase II clinical study of ALN-TTRsc in FAC patients by the end of 2013 and, assuming positive results, expects to start a pivotal trial for ALN-TTRsc in FAC patients in 2014.
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August 27, 2014
08:02 EDTALNYAlnylam receives notice of allowance from USPTO for new patent
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August 21, 2014
09:16 EDTALNYAlnylam to hold a roundtable webinar
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August 20, 2014
08:07 EDTALNYAlnylam receives USPTO notice of allowance for new patent
Alnylam Pharmaceuticals announced that the United States Patent and Trademark Office has issued a Notice of Allowance for claims in the Tuschl et al. patent application 13/725,262. The ’262 patent application includes newly allowed claims directed to compositions that mediate RNAi, and comprising a double-stranded molecule with up to 25 base pairs and at least one nucleotide analogue. Specifically, the newly allowed patent application broadly covers small interfering RNA molecules of various designs, including so-called “dicer substrate” RNAi triggers (Amarzguioui et al., Nat Protoc. 2006;1(2):508-17; Rose et al., Nucleic Acids Res. 2005 Jul 26;33(13):4140-56) and double-stranded, RNAi-mediating molecules containing moieties that include “unlocked nucleobase analogs” amongst other naturally or non-naturally occurring nucleotide analogues. The allowed claims of the Tuschl ’262 patent application, as well as other granted, Alnylam-owned or -licensed patents, in aggregate broadly cover compositions, methods, and uses of RNAi therapeutics.
August 19, 2014
15:50 EDTALNYAlnylam to hold a roundtable webinar
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