press release

March 14, 2018

CAMBRIDGE, Mass. (BUSINESS WIRE) Mar. 14, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, today announced that additional results from the APOLLO Phase 3 study of patisiran, an investigational therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis, will be presented at the 16th International Symposium on Amyloidosis (ISA), being held March 26 29, 2018 in Kumamoto, Japan. In ...

press release

March 12, 2018

− Company Plans to Accelerate Development with Phase 3 Start in Late 2018 − − Lumasiran Granted Breakthrough Therapy Designation by the United States Food and Drug Administration − CAMBRIDGE, Mass. (BUSINESS WIRE) Mar. 12, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that Sanofi Genzyme has declined its opt in for the development and commercialization ...

press release

February 8, 2018

– Reported Final Results from APOLLO Phase 3 Study and Completed Filings of New Drug Application (NDA) and Marketing Authorisation Application (MAA) for Patisiran, with an Expected Commercial Launch in U.S. and Europe in Mid and Late 2018, Respectively – – Advanced Three Additional RNAi Therapeutics in Phase 3 Development, Including Givosiran in ENVISION, Inclisiran in ORION 9, 10, and 11, ...

press release

December 18, 2017

– Patisiran MAA to be Reviewed Under Accelerated Assessment – CAMBRIDGE, Mass. & PARIS (BUSINESS WIRE) Dec. 18, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational ...

press release

December 15, 2017

– Clinical Trial Dosing to Resume Around Year End 2017 – CAMBRIDGE, Mass. & PARIS (BUSINESS WIRE) Dec. 15, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, ...

press release

December 12, 2017

– Patisiran Could Become the First in a New Class of Medicines Known as RNAi Therapeutics – CAMBRIDGE, Mass. (BUSINESS WIRE) Dec. 12, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for patisiran, an investigational ...

press release

December 11, 2017

CAMBRIDGE, Mass. (BUSINESS WIRE) Dec. 11, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today the U.S. Food and Drug Administration (FDA) has granted a request to amend the orphan drug designation for patisiran to the treatment of transthyretin mediated amyloidosis (ATTR amyloidosis). This is an expansion to patisiran’s prior designation which was for the treatment of ...

press release

November 20, 2017

– Designation Based on Positive APOLLO Phase 3 Study – CAMBRIDGE, Mass. (BUSINESS WIRE) Nov. 20, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin mediated ...

press release

November 16, 2017

− Company Plans to Complete Submission by Year End − CAMBRIDGE, Mass. (BUSINESS WIRE) Nov. 16, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR), for the ...

press release

November 13, 2017

− Company on Track to Submit Marketing Authorization Application (MAA) and New Drug Application (NDA) at Year End 2017 − CAMBRIDGE, Mass. (BUSINESS WIRE) Nov. 13, 2017 Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment for patisiran, ...