press release

July 13, 2020

– Positive Scientific Opinion Under Early Access to Medicines Scheme (EAMS) Will Make Lumasiran Treatment Available for UK Primary Hyperoxaluria Type 1 (PH1) Patients Before Marketing Authorization – Lumasiran Indicated Within EAMS for the Treatment of Patients with PH1 CAMBRIDGE, Mass. (BUSINESS WIRE) Jul. 13, 2020 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the ...

press release

July 8, 2020

ZUG, Switzerland & DUBAI, United Arab Emirates (BUSINESS WIRE) Jul. 8, 2020 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and taiba Middle East, a leading rare disease company based in the United Arab Emirates and covering the Middle East region, announced today that they have formed a Distribution Agreement for both ONPATTRO® and GIVLAARI®, the first ever ...

press release

June 30, 2020

− Long Term Givosiran Dosing Showed Sustained Reduction in Annualized Rate of Composite Porphyria Attacks (AAR) With a Median AAR of Zero and Over 60 Percent of Patients Attack Free in the Open Label Extension Period − − Safety Profile Consistent With That Observed in the 6 Month Double Blind Period, With No New Safety Findings − CAMBRIDGE, Mass. (BUSINESS WIRE) ...

press release

June 10, 2020

− The ENVISION Phase 3 Study Evaluated the Efficacy and Safety of Givosiran in Patients with Acute Hepatic Porphyria (AHP) − − Givosiran Demonstrated Significant Reduction in the Rate of Porphyria Attacks Compared with Placebo in Patients with AHP – CAMBRIDGE, Mass. (BUSINESS WIRE) Jun. 10, 2020 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that ...

press release

June 7, 2020

- Lumasiran Achieved Primary Endpoint with 53.5 Percent Mean Reduction in Urinary Oxalate Relative to Placebo and Showed a 65.4 Percent Reduction Relative to Baseline 84 Percent of Patients on Lumasiran Achieved Normal or Near Normal Levels of Urinary Oxalate and More than Half of Patients Reached Normalization, Compared with Zero Percent in the Placebo Group Lumasiran Demonstrated an Encouraging Safety ...

news

June 7, 2020

Even though the BIO International Convention has gone virtual for 2020 as a result of COVID 19, Alnylam leaders will continue to contribute to the informative, lively and always timely discourse that characterizes this annual biopharma event regarded by many as the "Superbowl" of the industry. This year, BIO Digital Week will consist of a mix of live and on demand sessions. Convention ...

press release

May 26, 2020

— PDUFA Date Set for December 3, 2020 — CAMBRIDGE, Mass. (BUSINESS WIRE) May 26, 2020 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding ...

press release

May 22, 2020

Patisiran Continues to Demonstrate Reversal of Neuropathy Progression, Improvement in Quality of Life, and Consistent Safety Profile with Additional 24 Months of Treatment in Global Open Label Extension (OLE) Study Interim Data Presented on Patisiran Treatment in Patients with Disease Progression After an Orthotopic Liver Transplant CAMBRIDGE, Mass. (BUSINESS WIRE) May 22, 2020 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading ...

press release

May 6, 2020

− Achieved First Quarter 2020 ONPATTRO® Net Product Revenues of $66.7 Million with More Than 950 Patients on Commercial Product Worldwide – − Achieved First Quarter 2020 GIVLAARI® Net Product Revenues of $5.3 Million with More Than 50 Patients on Commercial Product in the U.S. – – Completed New Drug Application and Filed Marketing Authorisation Application for Lumasiran, Advancing Another Alnylam ...

press release

April 14, 2020

CAMBRIDGE, Mass. (BUSINESS WIRE) Apr. 14, 2020 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to vutrisiran, an investigational therapeutic for the treatment of the polyneuropathy of hereditary transthyretin mediated (hATTR) amyloidosis in adults. According to the FDA, Fast Track designation is designed ...