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Alnylam Pharmaceuticals Inc (ALNY.OQ)

ALNY.OQ on NASDAQ Stock Exchange Global Select Market

124.83USD
19 Jan 2018
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$0.84 (+0.68%)
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Latest Key Developments (Source: Significant Developments)

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
Tuesday, 12 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

Arbutus’ LNP licensee Alnylam initiates rolling submission of NDA for Patisiran
Friday, 17 Nov 2017 

Nov 16 (Reuters) - Arbutus Biopharma Corp ::Arbutus’ LNP licensee Alnylam initiates rolling submission of New Drug Application (NDA) to U.S. Food and drug Administration (fda) for Patisiran.Says Alnylam expects to submit final clinical data for Patisiran by year end ​.  Full Article

Alnylam initiates rolling submission of NDA to U.S. FDA for HATTR amyloidosis treatment
Thursday, 16 Nov 2017 

Nov 16 (Reuters) - Alnylam Pharmaceuticals Inc :Alnylam initiates rolling submission of new drug application (NDA) to U.S. Food and drug administration (FDA) for patisiran for the treatment of hereditary ATTR (HATTR) amyloidosis.Alnylam Pharmaceuticals - ‍has also requested priority review of application for patisiran, if granted, could result in a 6-month review process ​.  Full Article

EMA grants Alnylam accelerated assessment of rare disease drug
Monday, 13 Nov 2017 

Nov 13 (Reuters) - Alnylam Pharmaceuticals Inc :European Medicines Agency (EMA) grants Alnylam accelerated assessment of patisiran for patients with hereditary attr (hattr) amyloidosis.Alnylam Pharmaceuticals Inc - ‍company on track to submit marketing authorization application (maa) and new drug application (nda) at year-end 2017​.Alnylam Pharmaceuticals Inc - ‍alnylam intends to file a marketing authorization application (maa) in european union (eu) at year-end 2017​.Alnylam Pharmaceuticals Inc - ‍alnylam plans to file a new drug application for patisiran in united states by end of 2017​.Alnylam Pharmaceuticals Inc - ‍pending regulatory approvals, alnylam will commercialize patisiran in u.s., canada and western europe​.Alnylam Pharmaceuticals Inc - ‍pending regulatory approvals sanofi genzyme commercializing product in rest of world​.  Full Article

Alnylam announces proposed public offering to raise about $675 mln
Monday, 13 Nov 2017 

Nov 13 (Reuters) - Alnylam Pharmaceuticals Inc -:Alnylam Pharmaceuticals announces proposed public offering of $675,000,000 of common stock.Alnylam Pharmaceuticals Inc - ‍commencement of underwritten public offering of shares of common stock to raise proceeds of about $675 million.  Full Article

BRIEF-Sanofi And Alnylam Pharmaceuticals Enter Into Partnership

* AND ALNYLAM, ANNOUNCED ON SUNDAY STRATEGIC RESTRUCTURING OF RNAI THERAPEUTICS RARE DISEASE ALLIANCE