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Alnylam Pharmaceuticals Inc (ALNY.OQ)

ALNY.OQ on NASDAQ Stock Exchange Global Select Market

94.58USD
17 Aug 2018
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Latest Key Developments (Source: Significant Developments)

Alnylam Pharmaceuticals' Gene Silencing Drug Patisiran (Onpattro) Approved By U.S. FDA - Website
Friday, 10 Aug 2018 

Aug 10 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS' GENE SILENCING DRUG PATISIRAN (ONPATTRO) APPROVED BY U.S. FDA - WEBSITE.  Full Article

Alnylam Announces FDA Approval Of Onpattro
Friday, 10 Aug 2018 

Aug 10 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM ANNOUNCES FIRST-EVER FDA APPROVAL OF AN RNAI THERAPEUTIC, ONPATTRO (PATISIRAN) FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS.ALNYLAM - ONPATTRO IS EXPECTED TO BE AVAILABLE FOR SHIPMENT TO HEALTHCARE PROVIDERS IN U.S. WITHIN 48 HOURS.  Full Article

FDA Approves Onpattro For Treatment For The Polyneuropathy Of hATTR In Adult Patients
Friday, 10 Aug 2018 

Aug 10 (Reuters) - U.S. Food and Drug Administration::U.S. FDA SAYS APPROVED ONPATTRO (PATISIRAN) INFUSION FOR TREATING POLYNEUROPATHY CAUSED BY HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULT PATIENTS.U.S. FDA SAYS APPROVAL OF ONPATTRO WAS GRANTED TO ALNYLAM PHARMACEUTICALS INC.  Full Article

Alnylam Reaches Settlement Agreement With Dicerna Pharmaceuticals
Friday, 20 Apr 2018 

April 20 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM REACHES SETTLEMENT AGREEMENT WITH DICERNA PHARMACEUTICALS RESOLVING TRADE SECRET MISAPPROPRIATION AND OTHER PENDING LITIGATION.ALNYLAM PHARMACEUTICALS INC - UNDER TERMS OF AGREEMENT, DICERNA WILL PAY $25 MILLION COMPRISED OF CASH AND STOCK TO ALNYLAM.ALNYLAM PHARMACEUTICALS INC - SETTLEMENT DOES NOT INCLUDE ANY LICENSE TO ALNYLAM'S GALNAC CONJUGATE INTELLECTUAL PROPERTY.ALNYLAM - AS PER SETTLEMENT, DICERNA WILL BE RESTRICTED IN ITS DEVELOPMENT RELATING TO OLIGONUCLEOTIDE-BASED THERAPEUTICS FOR A DEFINED SET OF CO'S TARGETS.ALNYLAM PHARMACEUTICALS - ALL OTHER SETTLEMENT TERMS ARE CONFIDENTIAL.  Full Article

Sanofi And Alnylam Pharmaceuticals Enter Into Partnership
Monday, 8 Jan 2018 

Jan 8 (Reuters) - SANOFI SA ::AND ALNYLAM, ANNOUNCED ON SUNDAY STRATEGIC RESTRUCTURING OF RNAI THERAPEUTICS RARE DISEASE ALLIANCE.SANOFI WILL OBTAIN GLOBAL DEVELOPMENT AND COMMERCIALIZATION RIGHTS TO FITUSIRAN.GLOBAL COMMERCIALIZATION OF FITUSIRAN, UPON APPROVAL, WILL BE DONE BY SANOFI GENZYME.ALNYLAM WILL RECEIVE ROYALTIES BASED ON NET SALES OF FITUSIRAN PRODUCTS.ALNYLAM TO OBTAIN GLOBAL DEVELOPMENT AND COMMERCIALIZATION RIGHTS TO ITS INVESTIGATIONAL RNAI THERAPEUTICS PROGRAMS FOR THE TREATMENT OF ATTR AMYLOIDOSIS, INCLUDING PATISIRAN AND ALN-TTRSC02.SANOFI WILL RECEIVE ROYALTIES BASED ON NET SALES OF THESE ATTR AMYLOIDOSIS PRODUCTS.  Full Article

‍Sanofi, Alnylam submit marketing authorization application to EMA for Patisiran
Monday, 18 Dec 2017 

Dec 18 (Reuters) - Sanofi statement::Sanofi and Alnylam submit Marketing Authorization Application to the European Medicines Agency for patisiran for the treatment of hereditary ATTR amyloidosis.‍Patisiran Marketing Authorization Application to be reviewed under accelerated assessment.Sanofi Genzyme is currently preparing regulatory filings for patisiran in Japan, Brazil and other countries, with submissions expected to begin in the first half of 2018. .Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world, including certain Central and Eastern European countries of the European Union. .​.  Full Article

FDA Lifts Clinical Hold On Fitusiran
Friday, 15 Dec 2017 

Dec 15 (Reuters) - Alnylam Pharmaceuticals Inc ::FDA LIFTS CLINICAL HOLD ON FITUSIRAN.FDA LIFTS CLINICAL HOLD ON FITUSIRAN.ALNYLAM PHARMACEUTICALS INC - CLINICAL TRIAL DOSING TO RESUME AROUND YEAR-END 2017.ALNYLAM - FDA LIFTED HOLD ON CLINICAL STUDIES WITH FITUSIRAN, INCLUDING PHASE 2 OPEN-LABEL EXTENSION STUDY, ATLAS PHASE 3 PROGRAM.ALNYLAM PHARMA - FDA HAS APPROVED PROTOCOL AMENDMENTS, OTHER UPDATED CLINICAL MATERIALS FOR FITUSIRAN STUDIES.ALNYLAM - CO, FDA HAD PREVIOUSLY REACHED ALIGNMENT ON NEW CLINICAL RISK MITIGATION MEASURES.  Full Article

Alnylam Completes NDA Submission To U.S. FDA For Patisiran For Treatment Of HATTR Amyloidosis
Tuesday, 12 Dec 2017 

Dec 12 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM COMPLETES SUBMISSION OF NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR PATISIRAN FOR THE TREATMENT OF HEREDITARY ATTR (HATTR) AMYLOIDOSIS.  Full Article

T. Rowe Price Associates Reports 11.7 Pct Passive Stake In Alnylam Pharmaceuticals
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Alnylam Pharmaceuticals Inc ::T. ROWE PRICE ASSOCIATES INC REPORTS 11.7 PERCENT PASSIVE STAKE IN ALNYLAM PHARMACEUTICALS INC AS OF NOVEMBER 30 - SEC FILING.  Full Article

FDA grants Alnylam breakthrough therapy designation for Patisiran
Monday, 20 Nov 2017 

Nov 20 (Reuters) - Alnylam Pharmaceuticals Inc :U.S. Food and Drug Administration (FDA) grants Alnylam breakthrough therapy designation (BTD) for Patisiran for the treatment of hereditary ATTR (HATTR) amyloidosis with polyneuropathy.Alnylam Pharmaceuticals Inc - ‍Alnylam has initiated a rolling new drug application (NDA) for Patisiran and expects last submission by end of 2017​.Alnylam - ‍co, in alliance with Sanofi Genzyme, intends to file a marketing authorization application in European Union around year-end for Patisiran​.  Full Article

UPDATE 1-Alnylam's gene silencing drug wins FDA approval

Aug 10 Alnylam Pharmaceuticals Inc's drug for a rare hereditary disease won U.S. regulatory approval on Friday, becoming the first approved treatment from a new class of medicines that use gene silencing technology.