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Alnylam Pharmaceuticals Inc (ALNY.OQ)

ALNY.OQ on NASDAQ Stock Exchange Global Select Market

118.82USD
17 Jan 2020
Change (% chg)

$-0.52 (-0.44%)
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Latest Key Developments (Source: Significant Developments)

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

Alnylam Says U.S. FDA Granted Priority Review For Acute Hepatic Porphyria Treatment Givosiran
Tuesday, 6 Aug 2019 

Aug 5 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM ANNOUNCES U.S. FOOD AND DRUG ADMINISTRATION (FDA) GRANTED PRIORITY REVIEW OF THE GIVOSIRAN NEW DRUG APPLICATION (NDA) FOR THE TREATMENT OF ACUTE HEPATIC PORPHYRIA.ALNYLAM PHARMACEUTICALS INC - FDA HAS INDICATED THAT THEY ARE NOT CURRENTLY PLANNING AN ADVISORY COMMITTEE MEETING AS PART OF NDA REVIEW.ALNYLAM PHARMACEUTICALS-FDA HAS SET ACTION DATE OF FEBRUARY 4, 2020 & INDICATED NOT CURRENTLY PLANNING ADVISORY COMMITTEE MEETING AS PART OF NDA REVIEW.  Full Article

Alnylam Pharmaceuticals Announces Transition Of CFO
Thursday, 11 Jul 2019 

July 11 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM PHARMACEUTICALS ANNOUNCES TRANSITION OF CHIEF FINANCIAL OFFICER.ALNYLAM PHARMACEUTICALS INC - ANNOUNCES PLANNED APPOINTMENT OF JEFF POULTON -.ALNYLAM PHARMACEUTICALS INC - MANMEET S. SONI TO RESIGN AFTER A TRANSITION PERIOD.ALNYLAM PHARMACEUTICALS INC - JEFF POULTON BEEN APPOINTED EXECUTIVE VICE PRESIDENT AND CHIEF FINANCIAL OFFICER (CFO), EFFECTIVE AUGUST 13, 2019.  Full Article

Arbutus Sells Part Of Its Onpattro Royalty Interest To Omers
Wednesday, 3 Jul 2019 

July 2 (Reuters) - Arbutus Biopharma Corp ::PRESS RELEASE - ARBUTUS SELLS PART OF ITS ONPATTRO™ (PATISIRAN) ROYALTY INTEREST TO OMERS.ARBUTUS BIOPHARMA CORP - ARBUTUS TO RECEIVE $20 MILLION IN GROSS PROCEEDS BEFORE ADVISORY FEES WHILE RETAINING SIGNIFICANT DOWNSTREAM ECONOMICS.ARBUTUS BIOPHARMA CORP - RUNWAY EXTENDED WITH NON-DILUTIVE CAPITAL.ARBUTUS BIOPHARMA CORP - ARBUTUS IS ENTITLED TO TIERED ROYALTY PAYMENTS ON NET SALES OF ONPATTRO RANGING FROM 1.00% - 2.33% AFTER OFFSETS.ARBUTUS BIOPHARMA CORP - ROYALTY INTEREST HAS BEEN SOLD TO OMERS, EFFECTIVE AS OF JANUARY 1, 2019, FOR $20 MILLION.  Full Article

Alnylam gene-silencing therapy to treat kidney disorder succeeds in late-stage study

Alnylam Pharmaceuticals Inc's gene-silencing therapy for a rare kidney disorder met the main goal of a late-stage study on Tuesday, bringing the company a step closer to marketing the first approved treatment for the condition.