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Alnylam Pharmaceuticals Inc (ALNY.OQ)

ALNY.OQ on NASDAQ Stock Exchange Global Select Market

104.62USD
19 Jun 2018
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Latest Key Developments (Source: Significant Developments)

Alnylam Pharma Co, Agilent Technologies Entered Manufacturing Services Agreement Providing For Supply Of Patisiran Drug Substance By Agilent
Tuesday, 3 Apr 2018 05:17pm EDT 

April 4 (Reuters) - Alnylam Pharmaceuticals ::CO, AGILENT TECHNOLOGIES ENTERED MANUFACTURING SERVICES AGREEMENT PROVIDING FOR SUPPLY OF PATISIRAN DRUG SUBSTANCE BY AGILENT.AGREEMENT HAS INITIAL TERM OF 5 YEARS, WHICH IS SUBJECT TO AUTOMATIC RENEWAL TERMS OF 2 YEARS.PURSUANT TO AGREEMENT, CO REQUIRED TO PROVIDE ROLLING FORECASTS FOR PRODUCT ON QUARTERLY BASIS.‍PURSUANT TO DEAL, AGILENT HAS AGREED TO MANUFACTURE, SUPPLY TO CO, ACTIVE PHARMACEUTICAL INGREDIENTS REQUIRED FOR PATISIRAN FOR COMMERCIAL SALE​.WILL BE REQUIRED TO PROVIDE INITIAL PAYMENT TO COVER RAW MATERIAL PURCHASES AND RESERVE APPROPRIATE RESOURCES UNDER AGREEMENT.  Full Article

Regeneron, Alnylam Pharmaceuticals Announce Collaboration To Discover New Treatments For Nonalcoholic Steatohepatitis
Wednesday, 21 Mar 2018 05:06pm EDT 

March 21 (Reuters) - Alnylam Pharmaceuticals Inc ::REGENERON AND ALNYLAM PHARMACEUTICALS ANNOUNCE COLLABORATION TO DISCOVER NEW TREATMENTS FOR NONALCOHOLIC STEATOHEPATITIS (NASH).ALNYLAM PHARMACEUTICALS INC - REGENERON WILL CONTRIBUTE RESEARCH ON HEPATOCYTE-EXPRESSED, GENETICALLY-VALIDATED HSD17B13 TARGET.ALNYLAM PHARMACEUTICALS INC - ALNYLAM WILL LEVERAGE ITS RNAI THERAPEUTICS PLATFORM TO IDENTIFY COMPOUNDS DIRECTED TO TARGET.ALNYLAM - CO, REGENERON INTEND TO ENTER SEPARATE, 50-50 COLLABORATION TO FURTHER RESEARCH, CO-DEVELOP ANY THERAPEUTIC PRODUCT COMING FROM DISCOVERY.  Full Article

Alnylam Retains Global Rights To Lumasiran, Investigational RNAi Therapeutic For Treatment Of Primary Hyperoxaluria Type 1
Monday, 12 Mar 2018 07:00am EDT 

March 12 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM RETAINS GLOBAL RIGHTS TO LUMASIRAN, AN INVESTIGATIONAL RNAI THERAPEUTIC FOR THE TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1).ALNYLAM PHARMACEUTICALS INC - ‍COMPANY PLANS TO ACCELERATE DEVELOPMENT WITH PHASE 3 START IN LATE 2018​.ALNYLAM PHARMACEUTICALS INC - ‍LUMASIRAN GRANTED BREAKTHROUGH THERAPY DESIGNATION BY UNITED STATES FOOD AND DRUG ADMINISTRATION​.ALNYLAM PHARMACEUTICALS INC - ‍SANOFI GENZYME HAS DECLINED ITS OPT-IN FOR DEVELOPMENT AND COMMERCIALIZATION OF LUMASIRAN​.  Full Article

Alnylam Pharmaceuticals Q4 Non-Gaap Loss Per Share $1.20
Thursday, 8 Feb 2018 08:00am EST 

Feb 8 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PERIOD ACTIVITY.Q4 NON-GAAP LOSS PER SHARE $1.20.EXPECTS TO END 2018 WITH APPROXIMATELY $1.0 BILLION IN CASH.REAFFIRMED GUIDANCE TO INITIATE A COMPREHENSIVE PHASE 3 PROGRAM FOR ALN-TTRSC02 IN LATE 2018.QTRLY LOSS PER SHARE $1.48.REVENUES WERE $37.9 MILLION IN Q4 OF 2017, AS COMPARED TO $17.5 MILLION IN Q4 OF 2016.Q4 EARNINGS PER SHARE VIEW $-1.39 -- THOMSON REUTERS I/B/E/S.EXPECTS 2018 ANNUAL NON-GAAP RESEARCH AND DEVELOPMENT EXPENSES TO BE IN RANGE OF $400 MILLION TO $440 MILLION.Q4 REVENUE VIEW $21.8 MILLION -- THOMSON REUTERS I/B/E/S.  Full Article

FDA Granted Alnylam's Request For Priority Review
Thursday, 1 Feb 2018 04:00pm EST 

Feb 1 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION (NDA) AND PRIORITY REVIEW STATUS FOR PATISIRAN, AN INVESTIGATIONAL RNAI THERAPEUTIC FOR THE TREATMENT OF HEREDITARY ATTR (HATTR) AMYLOIDOSIS.ALNYLAM PHARMACEUTICALS INC - FDA ALSO GRANTED COMPANY'S REQUEST FOR PRIORITY REVIEW AND HAS SET AN ACTION DATE OF AUGUST 11, 2018.ALNYLAM PHARMACEUTICALS INC - ‍AT THIS TIME, FDA IS NOT PLANNING TO HOLD AN ADVISORY COMMITTEE MEETING TO DISCUSS APPLICATION​.  Full Article

Sanofi And Alnylam Pharmaceuticals Enter Into Partnership
Monday, 8 Jan 2018 02:23am EST 

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 07:06am EST 

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 07:00am EST 

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 07:00am EST 

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 02:40pm EST 

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

BRIEF-Alnylam Pharmaceuticals Says On May 12, Co's Board Expanded Size Of Board From Ten To Eleven

* ALNYLAM PHARMACEUTICALS INC SAYS ON MAY 12, CO'S BOARD EXPANDED SIZE OF BOARD FROM TEN TO ELEVEN - SEC FILING Source http://bit.ly/2KrXrlM Further company coverage: