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press release

June 24, 2021

Alnylam Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Investigational Vutrisiran for the Treatment of the Polyneuropathy of Hereditary ATTR Amyloidosis

– PDUFA Date Set for April 14, 2022 – CAMBRIDGE, Mass. (BUSINESS WIRE) Jun. 24, 2021 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 vutrisiran, an investigational RNAi therapeutic for the treatment of the polyneuropathy of hereditary transthyretin mediated ...

press release

June 7, 2021

Alnylam Announces New Data from ATTR Amyloidosis Programs at the Peripheral Nerve Society’s 2021 Annual Meeting

− Phase 3b Open Label Study Showed Treatment with Patisiran Achieved Rapid and Sustained Reduction in Serum TTR Levels in hATTR Amyloidosis Patients with Polyneuropathy Progression Following Orthotopic Liver Transplant – − Additional Results from Pre specified Patient Subgroups Analysis Included with Encore Presentation of HELIOS A Phase 3 Study of Investigational VutrisiranCAMBRIDGE, Mass. (BUSINESS WIRE) Jun. 7, 2021 ...

press release

May 11, 2021

Alnylam Announces New Advances in ATTR Amyloidosis Program

− Initiates Clinical Study of Biannual Dosing Regimen of Investigational Vutrisiran in hATTR Patients with Polyneuropathy, with Data Expected in 2022 Potentially Supporting sNDA Submission – − Introduces New ATTR Program Aimed at Achieving Annual Dosing Regimen with Highly Potent and Reversible Effects; Expected IND Filing at or Around Year end 2022 – CAMBRIDGE, Mass. (BUSINESS WIRE) May 11, ...

press release

April 29, 2021

Alnylam Pharmaceuticals Reports First Quarter 2021 Financial Results and Highlights Recent Period Activity

− Achieved First Quarter 2021 Combined Net Product Revenues of $136 Million for ONPATTRO®, GIVLAARI®, and OXLUMO® – − Advanced Vutrisiran toward Market with Positive Results from HELIOS A Phase 3 Study and Submission of New Drug Application (NDA) with U.S. Food and Drug Administration (FDA) – – Launched “Alnylam P5x25” Strategy to Deliver Transformative Rare and Prevalent Disease Medicines for ...

press release

April 19, 2021

Alnylam Presents Positive Results from HELIOS-A Phase 3 Study of Investigational Vutrisiran

– At 9 Months, Vutrisiran Met Primary and All Secondary Endpoints, with Statistically Significant Improvements in Neuropathy, Quality of Life (QoL), and Gait Speed, Relative to Placebo – – In Majority of Patients, Vutrisiran Showed Reversal of Polyneuropathy Manifestations with Improvements in Neuropathy and QoL, Relative to Baseline – – Vutrisiran Also Met Key Exploratory Endpoints Including Measures of Nutritional Status, ...

press release

April 11, 2021

Alnylam Presents Positive Late-Breaking Data from Ongoing Phase 1 Study of ALN-AGT, an Investigational RNAi Therapeutic for the Treatment of Hypertension

– Single Doses of Investigational ALN AGT Achieved Sustained Reductions in Serum Angiotensinogen (AGT) at 12 Weeks Resulting in Reduced Blood Pressure – – Durability of AGT Knockdown Supports the Potential of Once Quarterly or Biannual Dosing – – ALN AGT was Generally Well Tolerated, with No Serious Treatment Related Adverse Events or Study Withdrawals – – Data Confirm Potential for ...

press release

March 23, 2021

Alnylam to Present Full 9-Month Results from the HELIOS-A Phase 3 Study of Vutrisiran at the American Academy of Neurology Virtual Annual Meeting 2021

– Alnylam to Share Additional Data From its RNAi Product Portfolio Including ATTR Amyloidosis and Acute Hepatic Porphyria – –Company to Host Conference Call April 19th at 4:00 pm ET to Discuss HELIOS A ResultsCAMBRIDGE, Mass. (BUSINESS WIRE) Mar. 23, 2021 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company will present full ...

press release

February 11, 2021

Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Highlights Recent Period Activity

− Achieved Fourth Quarter and Full Year 2020 Global Net Product Revenues of $113 Million and $362 Million, Respectively – − Achieved Regulatory Approvals of OXLUMO™ in the EU and U.S. and Leqvio®, by Partner Novartis, in the EU – – Launched “Alnylam P5x25” Strategy for Planned Transition to a Top Five Biotech in Market Capitalization Over the Next Five Years ...

press release

January 10, 2021

Alnylam Launches “Alnylam P⁵x25” Strategy for Planned Transition to a Top Five Biotech in Market Capitalization Over Next Five Years

– New 5 Year Strategy Represents Alnylam’s Commitment to Delivering Transformative Rare and Prevalent Disease Medicines for Patients Around the World Through Sustainable Innovation and Exceptional Financial Performance Driving Profitability – – In Addition, Company Announces Full Year 2020 Preliminary* Global Net Product Revenues for ONPATTRO® and GIVLAARI® of Approximately $306 Million and $55 Million, Respectively, and Strong Initial U.S. Demand ...

press release

January 7, 2021

Alnylam Reports Positive Topline Results from HELIOS-A Phase 3 Study of Vutrisiran in Patients with hATTR Amyloidosis with Polyneuropathy

Vutrisiran Met Primary and All Secondary Endpoints at 9 Months, with Statistically Significant Improvements in Progression of Neuropathy, Quality of Life (QOL), and Gait Speed, Relative to Placebo – – Majority of Patients Showed Reversal of Disease Manifestations with Improvements in Neuropathy Impairment and QOL, Relative to Baseline – – Vutrisiran Showed Improvements in the 9 Month Exploratory Cardiac Endpoint ...