press release

November 9, 2017

− Alignment Reached with FDA on Amended Safety Measures and Risk Mitigation Strategy to Enable Resumption of Fitusiran Clinical Program − − Reinitiation ofDosing Targeted Around Year End − CAMBRIDGE, Mass. (BUSINESS WIRE) Nov. 9, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today a successful Type A meeting with the U.S. Food and Drug Administration ...

press release

November 7, 2017

– Reported Positive APOLLO Phase 3 Results for Patisiran, with Plans for First New Drug Application (NDA) Filing by Year End – – Advanced Four RNAi Therapeutics in Late Stage Development, Including Initiation of ENVISION Phase 3 Study for Givosiran in Acute Hepatic Porphyrias – – Maintained Strong Balance Sheet with $1.15 Billion in Cash and Plans to End 2017 with Greater than $1 ...

press release

November 3, 2017

– Lumasiran Achieves Substantial Reductions in Urinary Oxalate Levels in all Patients, Highlighting Potential of Substrate Reduction Therapy in PH1 through RNAi mediated Glycolate Oxidase (GO) Inhibition – – Lumasiran Generally Well Tolerated with No Treatment Related Serious Adverse Events or Study Discontinuations up to Seven Months from Initial Dosing – CAMBRIDGE, Mass. (BUSINESS WIRE) Nov. 3, 2017 Alnylam Pharmaceuticals, ...

press release

November 2, 2017

– Patisiran Meets Primary Endpoint with a 34.0 Point Mean Difference Relative to Placebo and a Negative 6.0 Point Mean Change (Improvement) Relative to Baseline in Modified Neuropathy Impairment Score (mNIS+7) at 18 Months – – Patisiran Meets All Secondary Endpoints, Including a 21.1 Point Mean Difference Relative to Placebo and a Negative 6.7 Point Mean Change (Improvement) Relative to Baseline ...

press release

October 17, 2017

- Company Suspends Fitusiran Dosing due to Thrombotic Event and Aims to Resume Dosing as Soon as Possible upon Agreement with Global Regulatory Authorities Company Achieves Alignment with FDA on Givosiran Phase 3 Program Design, Including Interim Analysis Based on Reduction of Urinary Aminolevulinic Acid (ALA) as Surrogate Endpoint Reasonably Likely to Predict Clinical Benefit New ...

press release

October 17, 2017

- With up to 20 Months of Dosing, Fitusiran Safety and Tolerability Profile Remains Encouraging Once Monthly, Subcutaneous Fitusiran Achieves Median Annualized Bleeding Rate (ABR) of One for All Patients and Zero for Patients with Inhibitors in Exploratory Post hoc Analysis New England Journal of Medicine Publishes Phase 1 Clinical Results with Fitusiran in Patients with Hemophilia ...

press release

October 17, 2017

  New Data from an Ongoing Phase 2 Open label Extension Study with Fitusiran in Patients with Hemophilia A and B, With or Without Inhibitors CAMBRIDGE, Mass. (BUSINESS WIRE) Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced that new results from an ongoing Phase 2 open label extension (OLE) ...

press release

October 17, 2017

- ATLAS to Evaluate Safety and Efficacy of Fitusiran Across Broad Spectrum of Patients Living with Hemophilia CAMBRIDGE, Mass. (BUSINESS WIRE) Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today the initiation of the ATLAS Phase 3 clinical program for ...

press release

October 17, 2017

- In Randomized, Double Blind, Placebo Controlled Study, Givosiran Demonstrates Decreased Annualized Attack Rate and Hemin Usage Initial Results from Ongoing Open Label Extension (OLE) Study Show Consistent Reductions in Porphyria Attacks with Continued Givosiran Treatment Givosiran Administration Generally Well Tolerated with Treatment up to 12 Months Company Plans to Initiate Phase 3 Clinical Program in Late ...

press release

October 17, 2017

- Advanced Industry Leading RNAi Therapeutics Pipeline, Including Four Programs in Late Stage Development On Track to Report APOLLO Phase 3 Top Line Results for Patisiran in Near Term, and Initiated ATLAS Phase 3 Program for Fitusiran Maintained Strong Balance Sheet with $1.25 Billion in Cash and Plans to End 2017 with Greater than $1.0 Billion in Cash ...