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Alnylam Pharmaceuticals Inc (ALNY.OQ)

ALNY.OQ on NASDAQ Stock Exchange Global Select Market

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11 Dec 2018
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Latest Key Developments (Source: Significant Developments)

Alnylam Pharmaceuticals reports third quarter results
Wednesday, 7 Nov 2018 

Nov 7 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PERIOD ACTIVITY.Q3 LOSS PER SHARE $2.43.Q3 NON-GAAP LOSS PER SHARE $1.56.Q3 EARNINGS PER SHARE VIEW $-2.02 -- THOMSON REUTERS I/B/E/S.RECEIVED 125 U.S. PATIENT START FORMS IN FIRST SEVEN WEEKS OF ONPATTRO LAUNCH.ALNYLAM PHARMACEUTICALS - REPORTED POSITIVE TOPLINE INTERIM ANALYSIS RESULTS FROM ENVISION PHASE 3 STUDY OF GIVOSIRAN IN PATIENTS WITH ACUTE HEPATIC PORPHYRIAS.OBTAINED FDA AND EMA APPROVALS OF ONPATTRO™ (PATISIRAN) AND LAUNCHED IN U.S. AND EU.QTRLY TOTAL REVENUES $2.1 MILLION VERSUS $17.1 MILLION.COMPANY REITERATES ITS EXPECTATIONS FOR 2018 ANNUAL NON-GAAP RESEARCH AND DEVELOPMENT EXPENSES TO BE IN THE RANGE OF $420 MILLION TO $460 MILLION.  Full Article

Alnylam Reports Updated Positive Results From Phase 1/2 Study Of Lumasiran
Thursday, 4 Oct 2018 

Oct 4 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM REPORTS UPDATED POSITIVE RESULTS FROM PHASE 1/2 STUDY OF LUMASIRAN IN PATIENTS WITH PRIMARY HYPEROXALURIA TYPE 1.ALNYLAM PHARMACEUTICALS INC - LUMASIRAN SHOWS ENCOURAGING SAFETY PROFILE WITH A MEDIAN OF SEVEN MONTHS AND UP TO 14 MONTHS STUDY DURATION.ALNYLAM PHARMACEUTICALS INC - ALSO ANNOUNCED INITIATION OF ILLUMINATE-A, A GLOBAL PHASE 3 PIVOTAL TRIAL OF LUMASIRAN IN CHILDREN AND ADULTS WITH PH1.ALNYLAM PHARMACEUTICALS INC - LUMASIRAN TREATMENT RESULTED IN 75 PERCENT MEAN MAXIMAL REDUCTION IN URINARY OXALATE RELATIVE TO BASELINE.ALNYLAM PHARMACEUTICALS INC - EXPECTS TO REPORT TOPLINE RESULTS FROM ILLUMINATE-A IN LATE 2019.  Full Article

Alnylam Announces Positive Topline Results From Interim Analysis Of Envision Phase 3 Study Of Givosiran In Patients With Acute Hepatic Porphyria
Thursday, 27 Sep 2018 

Sept 27 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM ANNOUNCES POSITIVE TOPLINE RESULTS FROM INTERIM ANALYSIS OF ENVISION PHASE 3 STUDY OF GIVOSIRAN IN PATIENTS WITH ACUTE HEPATIC PORPHYRIA.ALNYLAM PHARMACEUTICALS INC - TOPLINE RESULTS ON PRIMARY ENDPOINT OF ANNUALIZED ATTACK RATE EXPECTED IN EARLY 2019.ALNYLAM PHARMACEUTICALS INC - TOPLINE RESULTS ON PRIMARY ENDPOINT OF ANNUALIZED ATTACK RATE EXPECTED IN EARLY 2019 -.ALNYLAM PHARMACEUTICALS INC - COMPANY PLANS TO DISCUSS RESULTS WITH FDA REGARDING A POTENTIAL NDA FILING AT OR AROUND YEAR-END IN SUPPORT OF AN ACCELERATED APPROVAL.ALNYLAM PHARMACEUTICALS INC - PLANS TO DISCUSS RESULTS WITH FDA REGARDING POTENTIAL NDA FILING AT OR AROUND YEAR-END IN SUPPORT OF AN ACCELERATED APPROVAL.ALNYLAM PHARMACEUTICALS - GIVOSIRAN TREATMENT RESULTED IN SIGNIFICANT REDUCTION OF URINARY AMINOLEVULINIC ACID.ALNYLAM PHARMACEUTICALS - NO DEATHS, AND SERIOUS ADVERSE EVENTS REPORTED IN 22 PERCENT OF GIVOSIRAN PATIENTS AND 10 PERCENT OF PLACEBO PATIENTS.  Full Article

Alnylam Completes Enrollment In Envision Phase 3 Study Of Givosiran
Tuesday, 21 Aug 2018 

Aug 21 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM COMPLETES ENROLLMENT IN ENVISION PHASE 3 STUDY OF GIVOSIRAN, AN INVESTIGATIONAL RNAI THERAPEUTIC FOR THE TREATMENT OF ACUTE HEPATIC PORPHYRIAS (AHPS).ALNYLAM PHARMACEUTICALS INC - ON TRACK TO REPORT INTERIM ANALYSIS DATA BY END OF SEPTEMBER AND FULL STUDY DATA IN EARLY 2019.ALNYLAM PHARMACEUTICALS INC - EXPECT TO SUBMIT AN NDA AT OR AROUND YEAR-END 2018, SEEKING AN ACCELERATED APPROVAL.  Full Article

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