Key Developments: Alnylam Pharmaceuticals Inc (ALNY.O)

ALNY.O on Nasdaq

27 Aug 2014
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Latest Key Developments (Source: Significant Developments)

Alnylam Pharmaceuticals Inc and The Alpha-1 Project (TAP) form collaboration
Thursday, 19 Jun 2014 08:58am EDT 

Alnylam Pharmaceuticals Inc and The Alpha-1 Project:Entered into collaboration agreement for continued advancement of ALN-AAT a subcutaneously administrated RNAi therapeutic in development for treatment of alpha-1 antitrypsin (AAT) deficiency-associated liver disease.Detailed financial terms of research agreement were not disclosed.Alnylam remains on track to file an investigational new drug (IND) application for this program in mid-2015.  Full Article

Alnylam Pharmaceuticals Inc announces United States Patent and Trademark Office (USPTO) issues patent covering RNAi Therapeutics for the Treatment of Hepatitis B Virus (HBV) Infection
Thursday, 12 Jun 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:Says that the United States Patent and Trademark Office (USPTO) has issued a new patent in the company's McSwiggen patent estate.McSwiggen patent estate broadly describes chemical modifications of RNAi therapeutics needed to achieve 'drug-like' properties in siRNA, the molecules that mediate RNAi.Specifically, the '277 patent includes claims that the company believes are critical for the development of RNAi therapeutics for the treatment of hepatitis B virus (HBV) infection.This patent is held exclusively by Alnylam and is not licensed to any third parties.McSwiggen patent estate comprises a core component of Alnylam's overall intellectual property (IP) estate for the advancement of RNAi therapeutics, and was recently obtained through the company's acquisition of Sirna Therapeutics from Merck.  Full Article

Alnylam Pharmaceuticals Inc presents new pre-clinical data with development candidate for ALN-CC5
Monday, 9 Jun 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:Says new pre-clinical results with its Development Candidate (DC) for ALN-CC5, a subcutaneously administered investigational RNAi therapeutic targeting complement component C5 in development for the treatment of complement-mediated diseases.New data demonstrate that ALN-CC5 led to up to 98.7 pct knockdown of serum C5 and an up to 96.8 pct inhibition of complement activity in non-human primates (NHP) with weekly subcutaneous dose administration.Alnylam believes that ALN-CC5 - part of company's 'Alnylam 5x15' product strategy - could represent novel approach for treatment of complement-mediated diseases, with potentially competitive profile compared with intravenously administered anti-C5 monoclonal antibody therapy.ALN-CC5 utilizes company's Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate technology, which enables subcutaneous dosing with increased potency and durability and a wide therapeutic index.ESC-GalNAc conjugates are a clinically validated platform based on recent preliminary Phase 1 study results from the company's ALN-AT3 program in development for the treatment of hemophilia.Company is on track to file its ALN-CC5 IND or IND equivalent in late 2014, and is guiding that it expects to present initial clinical results in mid-2015.  Full Article

Alnylam Pharmaceuticals reports initial positive top-line data from Phase 1 clinical trial with ALN-AT3
Tuesday, 13 May 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:Reports Initial Positive Top-Line Data from Phase 1 Clinical Trial with ALN-AT3, an RNAi Therapeutic Targeting Antithrombin (AT) in Development for the Treatment of Hemophilia and Rare Bleeding Disorders.Results Demonstrate Greater than 50-Fold Potency Improvement for Enhanced Stabilization Chemistry (ESC)-GalNAc-siRNA Conjugates in Humans, Representing an Unprecedented Advance in Delivery of RNAi Therapeutics with Subcutaneous Dose Administration.  Full Article

Alnylam Pharmaceuticals Inc announces new RNAi Therapeutic Program and reports an up to 2.3 log10 reduction of HBV surface antigen (HBsAg) in Chronically Infected Chimpanzees
Monday, 12 May 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:New RNAi Therapeutic Program for treatment of hepatitis B Virus Infection and Reports an Up to 2.3 Log10 Reduction of HBV Surface Antigen in Chronically Infected Chimpanzees.Use of nucleoside analog inhibitors of viral DNA synthesis and interferon therapies, less than 10 pct of patients achieve cure(1), Reduction in HBV surface antigen levels of over 0.5 log10 is single best predictor of immunologic cure(2).Alnylam reported significant, multi-log reductions in HBV surface antigen and HBV viral titers, and showed evidence for an immune-mediated therapeutic effect in chronically infected chimpanzees.  Full Article

Alnylam Pharmaceuticals Inc advances development candidate for ALN-AAT
Tuesday, 6 May 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:Advancing its Development Candidate (DC) for ALN-AAT, an RNAi therapeutic targeting alpha-1 antitrypsin (AAT) in development for the treatment of AAT deficiency-associated liver disease.ALN-AAT is one of Alnylam's genetic medicine programs, which are RNAi therapeutics directed toward genetically defined targets for treatment of diseases with high unmet medical need.AAT deficiency-associated liver disease is caused by accumulation of mutant AAT protein in liver tissue with subsequent liver injury, fibrosis, cirrhosis, and, in some cases, hepatocellular carcinoma.It is estimated that about 12,000 people with AAT deficiency in the U.S. and E.U. have associated liver pathology.Company plans to initiate IND-enabling studies with the goal of filing an IND or IND equivalent for ALN-AAT in mid-2015.  Full Article

Alnylam Pharmaceuticals Inc presents new pre-clinical data on RNAi therapeutics targeting Transthyretin for treatment of TTR-Mediated Amyloidosis
Tuesday, 29 Apr 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:Presentation of new pre-clinical data on RNAi therapeutics targeting transthyretin (TTR) for treatment of TTR-mediated amyloidosis.Data confirming that degree of TTR knockdown in a mouse disease model was highly correlated with regression of TTR tissue deposits.Further, comparative studies were performed with TTR stabilizer tafamidis and a TTR-specific antisense oligonucleotide (ASO).In these pre-clinical studies, RNAi therapeutics targeting TTR were shown to have superior pharmacologic profiles.These data suggest that the 80 pct TTR knockdown target level achieved with patisiran and ALN-TTRsc could facilitate a reduced pathogenic accumulation of TTR amyloid and possibly even a regression of TTR amyloid in patients with ATTR.These mice exhibit deposition of TTR at greater than 12 months of age in similar target organs to those seen in ATTR human disease, including dorsal root ganglion (DRG), sciatic nerve, duodenum, esophagus, stomach, and colon.Regression of TTR deposits was greater with every additional level of plasma TTR knockdown, and was most pronounced at the highest dose of siTTRsc tested, which achieved over 95 pct TTR knockdown.These results confirm that TTR knockdown of greater than 50 pct can lead to regression of TTR tissue deposits, but that the highest levels of TTR knockdown achievable remains the therapeutic objective for RNAi therapeutics.  Full Article

Alnylam Pharmaceuticals Inc present new clinical data for Patisiran
Monday, 28 Apr 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:New clinical data for patisiran (ALN-TTR02), an RNAi therapeutic targeting transthyretin (TTR) in development for treatment of TTR-mediated amyloidosis (ATTR).Frst company presented updated Phase 2 results in patients with Familial Amyloidotic Polyneuropathy (FAP) confirming robust TTR knockdown of up to 96 pct with mean TTR knockdown of about 80 pct.Furthe Alnylam presented preliminary results from open-label extension (OLE) study with patisiran in patients that were enrolled in the Phase 2 study.Preliminary results from OLE study showed that multiple doses of patisiran achieved sustained knockdown of serum TTR protein levels at the 80 pct target level through 168 days.Moreover, OLE results showed favorable tolerability profile with up to eight doses administered.Finally company presented results of a natural history, cross-sectional analysis study of 283 FAP patients aimed at measuring the rate of neuropathy progression and its correlation with disease severity.These results provide support for Alnylam's Phase 3 APOLLO trial where patisiran is being evaluated for its potential efficacy and safety in the FAP indication.  Full Article

Alnylam Pharmaceuticals Inc announces extension of lease agreement - Form 8-K
Wednesday, 2 Apr 2014 04:33pm EDT 

Alnylam Pharmaceuticals Inc:Company and Landlord entered into fifth amendment to lease.Company exercised its option to extend lease for an additional five years, through Sep. 30, 2021.Term of lease was set to expire in Sept. 2016.  Full Article

Alnylam receives positive opinion for orphan drug designation in the European Union for ALN-TTRsc
Wednesday, 2 Apr 2014 08:00am EDT 

Alnylam Pharmaceuticals Inc:Says that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product for the treatment of transthyretin (TTR)-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 about 15 patients.  Full Article

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