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Biomarin Pharmaceutical Inc (BMRN.OQ)

BMRN.OQ on NASDAQ Stock Exchange Global Select Market

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20 Sep 2019
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Latest Key Developments (Source: Significant Developments)

Biomarin Plans Regulatory Submissions For Marketing Authorization Of Valoctocogene Roxaparvovec
Monday, 8 Jul 2019 

July 8 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN PLANS REGULATORY SUBMISSIONS FOR MARKETING AUTHORIZATION OF VALOCTOCOGENE ROXAPARVOVEC TO TREAT SEVERE HEMOPHILIA A IN 4Q 2019 IN BOTH U.S. AND EUROPE.BIOMARIN PHARMACEUTICAL INC - SUBMISSIONS WILL BE BASED ON UPDATED THREE-YEAR PHASE 1/2 DATA AND RECENTLY COMPLETED PHASE 3 INTERIM ANALYSIS.BIOMARIN PHARMACEUTICAL INC - GENER8-1 TO COMPLETE ENROLLMENT IN EARLY FALL 2019.  Full Article

Biomarin Announces That Phase 3 Cohort Of Valoctocogene Roxaparvovec Met Pre-Specified Criteria For Regulatory Submissions In The U.S. And Europe
Tuesday, 28 May 2019 

May 28 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN ANNOUNCES THAT PHASE 3 COHORT OF VALOCTOCOGENE ROXAPARVOVEC, GENE THERAPY STUDY IN SEVERE HEMOPHILIA A MET PRE-SPECIFIED CRITERIA FOR REGULATORY SUBMISSIONS IN THE U.S. AND EUROPE.BIOMARIN PHARMA - WILL MEET FDA, EMA TO REVIEW PHASE 3 DATA, OTHER ELEMENTS OF A SUBMISSION; TO ANNOUNCE TIMING FOR MARKETING APPLICATIONS IN Q3.  Full Article

European Commission Approves Palynziq For Treatment Of Phenylketonuria (Pku) In Patients Aged 16 Years Or Older
Monday, 6 May 2019 

May 6 (Reuters) - Biomarin Pharmaceutical Inc ::EUROPEAN COMMISSION APPROVES PALYNZIQ® (PEGVALIASE INJECTION) FOR TREATMENT OF PHENYLKETONURIA (PKU) IN PATIENTS AGED 16 YEARS OR OLDER.BIOMARIN PHARMACEUTICAL - EC GRANTED MARKETING AUTHORIZATION FOR PALYNZIQ AT DOSES OF UP TO 60 MG ONCE DAILY FOR TREATING PKU IN PATIENTS 16 YRS OR OLDER.  Full Article

Biomarin Announces First Quarter 2019 Financial Results
Friday, 26 Apr 2019 

April 25 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN ANNOUNCES FIRST QUARTER 2019 FINANCIAL RESULTS.SEES FY 2019 REVENUE $1.68 BILLION TO $1.75 BILLION.Q1 REVENUE $400 MILLION VERSUS REFINITIV IBES ESTIMATE OF $389.7 MILLION.QTRLY LOSS PER SHARE $0.32.AS OF MARCH 31, HAD CASH, CASH EQUIVALENTS AND INVESTMENTS TOTALING ABOUT $1.2 BILLION VERSUS $1.3 BILLION ON DEC 31, 2018.Q1 EARNINGS PER SHARE VIEW $-0.19, REVENUE VIEW $389.7 MILLION -- REFINITIV IBES DATA.FY2019 REVENUE VIEW $1.69 BILLION -- REFINITIV IBES DATA.SEES 2019 GAAP NET LOSS OF $45 MILLION TO $85 MILLION.SEES 2019 NON-GAAP INCOME $130 MILLION TO $170 MILLION.SEES 2019 RESEARCH AND DEVELOPMENT EXPENSE $740 MILLION TO$780 MILLION.SEES 2019 VIMIZIM NET PRODUCT REVENUES $530 MILLION TO $570 MILLION.  Full Article

Biomarin Pharmaceutical Inc Sees 2018 Non-GAAP Net Income Of $90 Mln To $105 Mln
Wednesday, 9 Jan 2019 

Jan 8 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN PHARMACEUTICAL INC - 2018 FINAL FINANCIAL GUIDANCE LARGELY IN-LINE WITH PRIOR GUIDANCE.BIOMARIN PHARMACEUTICAL INC - REAFFIRMED Y/Y REVENUE GROWTH OF APPROXIMATELY 15% THROUGH 2020; $2 BILLION IN 2020.BIOMARIN PHARMACEUTICAL INC - NOW EXPECTS 2018 KUVAN NET PRODUCT REVNUE OF $430-$450 MILLION VERSUS PREVIOUS FORECAST OF $440-$480 MILLION.BIOMARIN PHARMACEUTICAL INC - SEES 2018 NON-GAAP NET INCOME OF $90 MILLION TO $105 MILLION VERSUS PREVIOUS FORECAST OF $100 MILLION TO $140 MILLION.BIOMARIN PHARMACEUTICAL INC - SEES 2018 GAAP NET LOSS OF $100 MILLION TO $115 MILLION VERSUS PREVIOUS FORECAST OF GAAP NET LOSS $115 MILLION TO $165 MILLION.  Full Article

Biomarin Receives Milestone Payments From Pfizer For Talzenna
Tuesday, 16 Oct 2018 

Oct 16 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES MILESTONE PAYMENTS FROM PFIZER FOR TALZENNA® (TALAZOPARIB) FOR METASTATIC BREAST CANCER PATIENTS WITH AN INHERITED BRCA MUTATION.BIOMARIN PHARMACEUTICAL INC - FDA APPROVAL TRIGGERS $15 MILLION PAYMENT.BIOMARIN PHARMACEUTICAL - ENTITLED TO EARN MID-SINGLE DIGIT ROYALTIES ON FUTURE SALES.  Full Article

Biomarin Pharmaceutical Reports Q1 Loss Per Share Of $0.25
Thursday, 26 Apr 2018 

April 25 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN ANNOUNCES FIRST QUARTER 2018 FINANCIAL RESULTS.Q1 REVENUE $373.4 MILLION VERSUS I/B/E/S VIEW $348.7 MILLION.Q1 GAAP LOSS PER SHARE $0.25.SEES FY 2018 REVENUE ABOUT $1.5 BILLION.Q1 EARNINGS PER SHARE VIEW $-0.17 -- THOMSON REUTERS I/B/E/S.AS OF MARCH 31, 2018, BIOMARIN HAD CASH, CASH EQUIVALENTS AND INVESTMENTS TOTALING ABOUT $1.7 BILLION.  Full Article

BioMarin Q4 GAAP Loss Per Share $0.30
Friday, 23 Feb 2018 

Feb 22 (Reuters) - BioMarin Pharmaceutical Inc ::BIOMARIN ANNOUNCES FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS.Q4 GAAP LOSS PER SHARE $0.30.QTRLY TOTAL REVENUES $358.3 MILLION VERSUS $300.1 MILLION.SEES 2018 TOTAL REVENUES $1,470 MILLION TO $1,530 MILLION.SEES 2018 GAAP NET LOSS OF $115 MILLION TO $165 MILLION.SEES 2018 NON-GAAP INCOME OF $100 MILLION TO $140 MILLION.Q4 REVENUE VIEW $351.6 MILLION -- THOMSON REUTERS I/B/E/S.FY2018 REVENUE VIEW $1.48 BILLION -- THOMSON REUTERS I/B/E/S.  Full Article

Biomarin Receives Anticipated Notification Of PDUFA Extension For Pegvaliase Biologics License Application
Friday, 22 Dec 2017 

Dec 22 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES ANTICIPATED NOTIFICATION OF PDUFA EXTENSION FOR PEGVALIASE BIOLOGICS LICENSE APPLICATION (BLA) TO MAY 28, 2018.BIOMARIN PHARMACEUTICAL INC - U.S. FDA WILL REQUIRE ADDITIONAL TIME TO COMPLETE ITS REVIEW OF BIOLOGICS LICENSE APPLICATION FOR PEGVALIASE.BIOMARIN PHARMACEUTICAL INC - ACTION GOAL DATE FOR PEGVALIASE BIOLOGICS LICENSE APPLICATION WILL BE MAY 25, 2018.  Full Article

Biomarin Sells Second Priority Review Voucher For $125 Mln
Monday, 27 Nov 2017 

Nov 27 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN SELLS SECOND PRIORITY REVIEW VOUCHER FOR $125 MILLION.BIOMARIN PHARMACEUTICAL INC - ‍ENTERED AGREEMENT TO SELL RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER IT OBTAINED IN APRIL OF THIS YEAR​.BIOMARIN PHARMACEUTICAL - ‍SALE OF PRV WILL BE RECORDED AS A $125 MILLION GAIN ON SALE OF AN INTANGIBLE ASSET.BIOMARIN PHARMACEUTICAL INC - ‍NON-GAAP INCOME GUIDANCE FOR FULL-YEAR 2017 IS UNCHANGED AT $60 TO $80 MILLION​.BIOMARIN PHARMACEUTICAL INC- ‍FOR FULL YEAR 2017, GAAP NET LOSS GUIDANCE WILL BE REDUCED TO BETWEEN $10 MILLION AND $30 MILLION​.  Full Article

BioMarin says data shows hemophilia gene therapy effects could wane

BioMarin Pharmaceutical Inc said on Tuesday early trial data for its gene therapy for hemophilia A suggested the one-time infusion's effect on some patients' bleeding disorders would last eight years.