Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, discovers, develops, and commercializes novel therapeutics based on RNA interference. The company’s clinical development programs include Patisiran and Revusiran, which are in Phase III clinical trials for the treatment of transthyretin amyloidosis (ATTR); ALN-TTRsc02, an investigational RNAi therapeutic targeting TTR for the treatment of various forms of ATTR amyloidosis; Fitusiran, an investigational RNAi therapeutic that is in Phase I clinical trial for the treatment of hemophilia and rare bleeding disorders; ALN-CC5, which is in Phase I/II clinical trial for the treatment of complement-mediated diseases; and ALN-AS1 for the trea...
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Founded in 2002
Alnylam Completes Enrollment in ENDEAVOUR Phase 3 Study with Revusiran, an Investigational RNAi Therapeutic for Patients with Hereditary ATTR Amyloidosis with Cardiomyopathy (hATTR-CM)
Aug 8 16
Alnylam Pharmaceuticals, Inc. announced that it has completed enrollment in its ENDEAVOUR Phase 3 study with revusiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR amyloidosis with cardiomyopathy (hATTR-CM), also known as familial amyloidotic cardiomyopathy (FAC). The ENDEAVOUR trial enrolled 206 patients with hATTR-CM, above the enrollment target of 200 patients. The company expects to report data from the study in early 2018. The ENDEAVOUR Phase 3 trial is a randomized, double-blind, placebo-controlled, global study designed to evaluate the efficacy and safety of revusiran in patients with hATTR-CM. The co-primary endpoints of the study are the change compared to baseline in six-minute walk distance (6-MWD) and the percent reduction in TTR level between placebo- and revusiran-treated patients at 18 months. Secondary endpoints include a composite endpoint of cardiovascular (CV) mortality and cardiovascular hospitalization, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), and all-cause mortality. The trial was designed to enroll up to 200 hATTR-CM patients with a documented TTR mutation, including V122I or other mutations, in addition to amyloid deposits as identified by biopsy or technetium scan. Patients were randomized 2:1, revusiran to placebo, with revusiran administered subcutaneously at 500 mg daily for five days then weekly for 18 months. All patients completing the ENDEAVOUR Phase 3 study may be eligible to enroll in a Phase 3 open-label extension (OLE) study (ENDEAVOUR-OLE).
Alnylam Pharmaceuticals, Inc. Reports Unaudited Consolidated Financial Results for the Second Quarter and Six Months Ended June 30, 2016; Provides Earnings Guidance for the Second Half of 2016
Aug 4 16
Alnylam Pharmaceuticals, Inc. reported unaudited consolidated financial results for the second quarter and six months ended June 30, 2016. For the quarter, the company reported net revenues from collaborators of $8,709,000 against $8,685,000 a year ago. Loss from operations was $92,450,000 against $72,944,000 a year ago. Loss before income taxes was $90,129,000 against $71,352,000 a year ago. Net loss was $90,129,000 or $1.05 per basic and diluted share against $71,783,000 or $0.85 per basic and diluted share a year ago.
For the six months, the company reported net revenues from collaborators of $16,054,000 against $27,222,000 a year ago. Loss from operations was $202,478,000 against $125,166,000 a year ago. Loss before income taxes was $193,103,000 against $122,560,000 a year ago. Net loss was $193,103,000 or $2.26 per basic and diluted share against $122,560,000 or $1.47 per basic and diluted share a year ago.
The company expects net revenues from collaborators to increase during the second half of 2016 due to an expected increase in expense reimbursement from Sanofi Genzyme. The company expects that G&A expenses during the second half of 2016 will remain relatively consistent with the first half of 2016 and that R&D expenses during the second half of 2016 will increase compared to the first half of 2016 as it continues to develop its pipeline and advance its product candidates into clinical trials, but that such expenses will be variable on a quarterly basis depending on the timing of manufacturing batches, clinical trial enrollment, and non-cash stock-based compensation expenses.
Alnylam Pharmaceuticals, Inc. Presents at 36th Annual Canaccord Genuity Growth Conference 2016, Aug-10-2016 11:00 AM
Aug 3 16
Alnylam Pharmaceuticals, Inc. Presents at 36th Annual Canaccord Genuity Growth Conference 2016, Aug-10-2016 11:00 AM. Venue: InterContinental Hotel, Boston, Massachusetts, United States.