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Alnylam Pharmaceuticals Inc (ALNY.OQ)

ALNY.OQ on NASDAQ Stock Exchange Global Select Market

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8 Apr 2020
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Latest Key Developments (Source: Significant Developments)

Alnylam Completes Rolling Submission Of New Drug Application To The U.S. FDA For Lumasiran For The Treatment Of Primary Hyperoxaluria Type 1
Tuesday, 7 Apr 2020 

April 7 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM COMPLETES ROLLING SUBMISSION OF NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION AND SUBMITS MARKETING AUTHORIZATION APPLICATION TO THE EUROPEAN MEDICINES AGENCY FOR LUMASIRAN FOR THE TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1.  Full Article

Vir And Alnylam Expand Collaboration To Advance RNAi Therapeutics For Treatment Of Coronavirus Infection, Including Covid-19
Wednesday, 4 Mar 2020 

March 4 (Reuters) - Alnylam Pharmaceuticals Inc ::VIR AND ALNYLAM EXPAND COLLABORATION TO ADVANCE RNAI THERAPEUTICS FOR THE TREATMENT OF CORONAVIRUS INFECTION, INCLUDING COVID-19.ALNYLAM PHARMA - RECENT ALNYLAM ADVANCES IN LUNG DELIVERY TECHNOLOGY SUGGEST POSSIBLE UTILITY OF SIRNAS IN TARGETING SARS-COV-2.ALNYLAM PHARMACEUTICALS - VIR TO LEAD DEVELOPMENT OF POTENTIAL CORONAVIRUS RNAI THERAPEUTIC CANDIDATES, WITH CO RETAINING OPTION FOR 50-50 PARTICIPATION.ALNYLAM PHARMA - FOCUS ON DEVELOPMENT OF SIRNAS THAT ALNYLAM IDENTIFIED THAT TARGET HIGHLY CONSERVED REGIONS OF CORONAVIRUS RNAS.ALNYLAM PHARM - MAY ELECT TO EARN DEVELOPMENT, COMMERCIALIZATION MILESTONES & ROYALTIES ON NET SALES OF PRODUCTS FOR CORONAVIRUS PROGRAM.  Full Article

Alnylam Pharmaceuticals Reports Q4 Net Product Revenues Of $55.9 Mln
Thursday, 6 Feb 2020 

Feb 6 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PERIOD ACTIVITY.ALNYLAM PHARMACEUTICALS INC - NET PRODUCT REVENUES WERE $55.9 MILLION IN Q4 2019 REPRESENTING 21% GROWTH FROM Q3 2019.ALNYLAM PHARMACEUTICALS INC QTRLY GAAP NET LOSS PER COMMON SHARE - BASIC AND DILUTED $2.47.ALNYLAM PHARMACEUTICALS INC QTRLY ADJUSTED LOSS PER SHARE $1.98.ALNYLAM PHARMACEUTICALS INC SEES 2020 ONPATTRO NET PRODUCT REVENUES OF $285 MILLION - $315 MILLION.ALNYLAM PHARMACEUTICALS INC SEES 2020 NET REVENUES FROM COLLABORATORS OF $100 MILLION - $150 MILLION.ALNYLAM PHARMACEUTICALS INC SEES 2020 NON-GAAP RESEARCH AND DEVELOPMENT AND SG&A EXPENSES OF $1,025 MILLION - $1,125 MILLION.ALNYLAM PHARMACEUTICALS INC SEES 2020 GAAP RESEARCH AND DEVELOPMENT AND SG&A EXPENSES OF $1,180 MILLION - $1,300 MILLION.  Full Article

Alnylam Initiates Rolling Submission Of NDA For Lumasiran For The Treatment Of PH1
Saturday, 11 Jan 2020 

Jan 10 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM INITIATES ROLLING SUBMISSION OF NEW DRUG APPLICATION (NDA) TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR LUMASIRAN FOR THE TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1).ALNYLAM INITIATES ROLLING SUBMISSION OF NEW DRUG APPLICATION (NDA) TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR LUMASIRAN FOR THE TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1).ALNYLAM PHARMACEUTICALS INC - COMPANY PLANS TO COMPLETE SUBMISSION IN EARLY 2020.ALNYLAM PHARMACEUTICALS INC - LUMASIRAN GRANTED PEDIATRIC RARE DISEASE DESIGNATION BY FDA FOR TREATMENT OF PH1.ALNYLAM PHARMACEUTICALS INC - INTENDS TO FILE A MARKETING AUTHORISATION APPLICATION WITH EMA IN EARLY 2020.  Full Article

Alnylam Reports Positive Topline Results From ILLUMINATE-A Phase 3 Study Of Lumasiran For The Treatment Of Primary Hyperoxaluria Type 1
Tuesday, 17 Dec 2019 

Dec 17 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM REPORTS POSITIVE TOPLINE RESULTS FROM ILLUMINATE-A PHASE 3 STUDY OF LUMASIRAN FOR TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1.ALNYLAM PHARMA - LUMASIRAN MET PRIMARY AND ALL TESTED SECONDARY ENDPOINTS, WITH SIGNIFICANT REDUCTION IN URINARY OXALATE LEVELS RELATIVE TO PLACEBO.ALNYLAM PHARMACEUTICALS - INTENDS TO FILE NDA AND MARKETING AUTHORISATION APPLICATION FOR LUMASIRAN IN EARLY 2020.ALNYLAM PHARMACEUTICALS - LUMASIRAN ALSO DEMONSTRATED ENCOURAGING SAFETY AND TOLERABILITY PROFILE IN ILLUMINATE-A PHASE 3 STUDY.  Full Article

Alnylam Announces 2020 Product and Pipeline Goals
Friday, 22 Nov 2019 

Nov 22 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS INC - ANNOUNCES 2020 PRODUCT AND PIPELINE GOALS AND PROVIDES UPDATES AT RESEARCH AND DEVELOPMENT DAY.ALNYLAM PHARMACEUTICALS INC - EXPECTS TO EXCEED ALNYLAM 2020 GOALS WITH FOUR MARKETED PRODUCTS, 14 ORGANIC CLINICAL STAGE PROGRAMS BY END OF 2020.ALNYLAM PHARMACEUTICALS - PLANS TO GET APPROVAL OF ONPATTRO IN BRAZIL IN MID-2020, WITH PLANNED LAUNCHES IN ADDITIONAL COUNTRIES THROUGHOUT 2020.ALNYLAM PHARMACEUTICALS - PLANS TO ACHIEVE REGULATORY APPROVAL FROM EUROPEAN MEDICINES AGENCY IN EARLY 2020 FOR GIVLAARI.ALNYLAM PHARMACEUTICALS INC - PLANS TO REPORT TOPLINE RESULTS FROM ILLUMINATE-B PEDIATRIC PHASE 3 STUDY IN MID-2020.ALNYLAM PHARMACEUTICALS INC - PLANS TO SUPPORT MEDICINES COMPANY'S EFFORTS WITH RESPECT TO ORION PHASE 3 STUDIES OF INCLISIRAN.  Full Article

FDA Says Granted Approval To Givlaari For Treatment Of Acute Hepatic Porphyria
Wednesday, 20 Nov 2019 

Nov 20 (Reuters) - U.S. Food and Drug Administration::FDA SAYS GRANTED APPROVAL TO GIVLAARI (GIVOSIRAN) FOR TREATMENT OF ADULT PATIENTS WITH ACUTE HEPATIC PORPHYRIA.FDA SAYS GRANTED APPROVAL OF GIVLAARI TO ALNYLAM PHARMACEUTICALS.  Full Article

Alnylam Pharmaceuticals Reports Q3 Results
Thursday, 31 Oct 2019 

Oct 31 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS REPORTS THIRD QUARTER 2019 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PERIOD ACTIVITY.Q3 NON-GAAP LOSS PER SHARE $1.50.Q3 GAAP LOSS PER SHARE $1.92.Q3 EARNINGS PER SHARE ESTIMATE $-2.04 -- REFINITIV IBES DATA.QTRLY TOTAL REVENUES $70.1 MILLION VERSUS $2.1 MILLION.EXPECTS ITS CURRENT CASH, CASH EQUIVALENTS, AND MARKETABLE DEBT SECURITIES WILL SUPPORT COMPANY OPERATIONS FOR MULTIPLE YEARS.ALNYLAM PHARMACEUTICALS - REITERATES EXPECTATIONS FOR 2019 NON-GAAP RESEARCH AND DEVELOPMENT EXPENSES TO BE IN RANGE OF $550 TO $575 MILLION.ALNYLAM PHARMACEUTICALS - REITERATES EXPECTATIONS FOR 201 NON-GAAP SG&A EXPENSES TO BE IN RANGE OF $390 TO $400 MILLION.Q3 REVENUE VIEW $56.4 MILLION -- REFINITIV IBES DATA.  Full Article

Alnylam Announces Filing For Marketing Authorization Of Onpattro In Brazil For The Treatment Of Hereditary ATTR Amyloidosis With Polyneuropathy
Thursday, 10 Oct 2019 

Oct 10 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM ANNOUNCES FILING FOR MARKETING AUTHORIZATION OF ONPATTRO® (PATISIRAN) IN BRAZIL FOR THE TREATMENT OF HEREDITARY ATTR AMYLOIDOSIS WITH POLYNEUROPATHY.ALNYLAM PHARMACEUTICALS - ALNYLAM EXPECTS A DECISION FROM ANVISA IN FIRST HALF OF 2020.ALNYLAM PHARMACEUTICALS - SUBMISSION OF MARKETING AUTHORIZATION OF ONPATTRO (PATISIRAN) MADE UNDER ACCELERATED REGULATORY PATHWAY FOR RARE DISEASES.  Full Article

Alnylam Pharmaceuticals Reports Second Quarter 2019 Financial Results And Highlights Recent Period Activity
Tuesday, 6 Aug 2019 

Aug 6 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PERIOD ACTIVITY.Q2 NON-GAAP LOSS PER SHARE $1.83.Q2 EARNINGS PER SHARE ESTIMATE $-1.86 -- REFINITIV IBES DATA.SEES 2019 ANNUAL NON-GAAP RESEARCH AND DEVELOPMENT EXPENSES TO BE IN RANGE OF $550 TO $575 MILLION.SEES 2019 NON-GAAP SG&A EXPENSES TO BE IN RANGE OF $390 TO $400.ALNYLAM PHARMACEUTICALS-CASH, CASH EQUIVALENTS, MARKETABLE DEBT SECURITIES WILL SUPPORT OPERATIONS FOR MULTIPLE YEARS BASED ON CURRENT OPERATING PLAN.LOWERS 2019 NON-GAAP RESEARCH AND DEVELOPMENT AND NON-GAAP SG&A EXPENSE GUIDANCE.ENDED Q2 WITH APPROXIMATELY $2.0 BILLION IN CASH.  Full Article

BRIEF-Alnylam Completes Rolling Submission Of New Drug Application To The U.S. FDA For Lumasiran For The Treatment Of Primary Hyperoxaluria Type 1

* ALNYLAM COMPLETES ROLLING SUBMISSION OF NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION AND SUBMITS MARKETING AUTHORIZATION APPLICATION TO THE EUROPEAN MEDICINES AGENCY FOR LUMASIRAN FOR THE TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)