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Last $125.46 USD
Change Today -4.63 / -3.56%
Volume 580.9K
As of 8:10 PM 07/30/15 All times are local (Market data is delayed by at least 15 minutes).

alnylam pharmaceuticals inc (ALNY) Key Developments

Alnylam Pharmaceuticals, Inc. - Special Call

To consider ALN-HBV for the treatment of Hepatitis B Virus (HBV) Infection

Alnylam Initiates Phase 1/2 Clinical Trial for ALN-AAT, an Investigational RNAi Therapeutic for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (Alpha-1 Liver Disease)

Alnylam Pharmaceuticals, Inc. announced that it has initiated a Phase 1/2 clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency-associated liver disease (alpha-1 liver disease). The Phase 1/2 trial will be conducted initially in normal healthy volunteers, and, then, in patients with alpha-1 liver disease. Initiation of this trial is based on encouraging pre-clinical data presented at the Digestive Disease Week (DDW) meeting May 16 - 19, 2015. The company expects to present initial clinical data from this trial in early 2016. ALN-AAT is a subcutaneously administered investigational RNAi therapeutic that utilizes Alnylam’s proprietary ESC-GalNAc-siRNA conjugate delivery technology. ESC-GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor, and enable subcutaneous dosing with increased potency and durability and a wide therapeutic index. As per the filed CTA, the Phase 1/2 trial of ALN-AAT is a randomized, single-blind, placebo-controlled study being conducted in three parts. Parts A and B are single-dose (Part A) and multi-dose (Part B), dose-escalation studies, designed to enroll up to a total of 48 healthy adult volunteers. Part C will be a multi-dose study designed to enroll up to a total of 24 adults with alpha-1 liver disease and mild-to-moderate liver fibrosis. The primary objective of the study is to evaluate safety and tolerability of single and multiple subcutaneous doses of ALN-AAT. Secondary objectives include evaluation of pharmacokinetics and clinical activity for ALN-AAT as measured by knockdown of serum AAT. In addition, biopsies will be obtained from subjects with alpha-1 liver disease to quantify the effects of treatment on levels of periodic acid-Schiff (PAS)-stained globules, a measure of misfolded AAT accumulation observed in the livers of alpha-1 liver disease patients.

Alnylam Pharmaceuticals, Inc. - Special Call

RNAi Roundtable: ALN-AT3 for the treatment of Hemophilia and Rare Bleeding Disorders

Alnylam Pharmaceuticals, Inc. Initiates Phase 3 Open Label Extension Study

Alnylam Pharmaceuticals, Inc. announced that it has initiated its Phase 3 open-label extension study (abbreviated APOLLO-OLE) with patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR amyloidosis) in patients with Familial Amyloidotic Polyneuropthy (FAP). All patients who complete the APOLLO Phase 3 trial with patisiran are eligible to enroll in APOLLO-OLE. The study will evaluate the long-term safety and efficacy of patisiran and will also measure effects of treatment toward a number of clinical endpoints, including the modified Neuropathy Impairment Score, or mNIS+7, which is an evaluation of muscle weakness, sensory and autonomic function, and nerve conductance. The company is also reiterating its previous guidance that assuming positive study results in the APOLLO Phase 3 study it expects to be in a position to file a New Drug Application (NDA) for patisiran in the 2017 timeframe.

Alnylam Pharmaceuticals, Inc. - Special Call

To discuss on new interim Phase 1 results with ALN-AT3i

 

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ALNY

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Valuation ALNY Industry Range
Price/Earnings NM Not Meaningful
Price/Sales 175.5x
Price/Book 7.3x
Price/Cash Flow NM Not Meaningful
TEV/Sales 162.7x
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