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Biomarin Pharmaceutical Inc (BMRN.OQ)

BMRN.OQ on NASDAQ Stock Exchange Global Select Market

88.55USD
25 Mar 2019
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Latest Key Developments (Source: Significant Developments)

Biomarin Receives Positive CHMP Opinion In Europe For Palynziq
Friday, 1 Mar 2019 

March 1 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES POSITIVE CHMP OPINION IN EUROPE FOR PALYNZIQ® (PEGVALIASE INJECTION) FOR TREATMENT OF PATIENTS WITH PHENYLKETONURIA (PKU) AGED 16 AND OLDER.BIOMARIN PHARMACEUTICAL INC - DECISION ON MARKETING AUTHORIZATION APPLICATION EXPECTED Q2 '19 FOR PALYNZIQ.BIOMARIN PHARMACEUTICAL - CHMP NOTED DATA COLLECTED IN PHASE 3 TRIAL & EXTENSION STUDY WAS SUGGESTIVE OF IMPROVEMENT IN INATTENTION AND MOOD SYMPTOMS.  Full Article

Biomarin Announces Full Year And Fourth Quarter 2018 Results
Thursday, 21 Feb 2019 

Feb 21 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN ANNOUNCES FULL YEAR AND FOURTH QUARTER 2018 RESULTS.QTRLY LOSS PER SHARE $0.03.QTRLY TOTAL REVENUES $353.2 MILLION VERSUS $358.3 MILLION.Q4 EARNINGS PER SHARE VIEW $-0.25, REVENUE VIEW $377.1 MILLION -- REFINITIV IBES DATA.GLOBAL PHASE 3 VOSORITIDE STUDY IN CHILDREN WITH ACHONDROPLASIA ENROLLMENT COMPLETE WITH DATA EXPECTED BY YEAR-END 2019.IN EUROPE, CHMP OPINION FOR PALYNZIQ ANTICIPATED IN Q1 2019.ENROLLMENT COMPLETE FOR ACCELERATED FILING REQUIREMENTS FOR VALOCTOCOGENE ROXAPARVOVEC FOR HEMOPHILIA A.SEES 2019 TOTAL REVENUES $1,680 TO $1,750 MILLION.FY2019 REVENUE VIEW $1.73 BILLION -- REFINITIV IBES DATA.SEES 2019 NON-GAAP INCOME $130 TO $170 MILLION.  Full Article

Biomarin Sees 2019 Revenue Guidance For Palynziq Of $70 Mln To $100 mln
Monday, 7 Jan 2019 

Jan 7 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN PHARMACEUTICAL INC - PHASE 3 VOSORITIDE DATA IN CHILDREN WITH ACHONDROPLASIA EXPECTED YEAR END 2019.BIOMARIN PHARMACEUTICAL - SEES 2019 REVENUE GUIDANCE FOR PALYNZIQ OF $70 MILLION TO $100 MILLION.BIOMARIN PHARMACEUTICAL -CHMP OPINION FOR PALYNZIQ INJECTION FOR PATIENTS 16 & OLDER WITH PKU ANTICIPATED IN 1Q19 & POTENTIAL APPROVAL IN EU IN 2Q19.  Full Article

Biomarin Pharmaceutical Inc - Pku gene therapy planned IND for 2H 2019
Wednesday, 7 Nov 2018 

Nov 7 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN PHARMACEUTICAL INC - PKU GENE THERAPY PLANNED IND FOR 2H 2019.BIOMARIN PHARMACEUTICAL INC - PHASE 3 STUDY OF VOSORITIDE IN CHILDREN IS NOW FULLY ENROLLED AND TOP LINE RESULTS ARE PLANNED FOR END OF 2019.BIOMARIN - BASED ON FDA FEEDBACK & INTERIM RESULTS, WILL TARGET 2H OF 2019 TO SUBMIT A BIOLOGIC LICENSE APPLICATION (BLA) FOR ACCELERATED APPROVAL..BIOMARIN PHARMACEUTICAL INC - BIOMARIN PLANS TO FILE AN INVESTIGATIONAL NEW DRUG APPLICATION (IND) FOR BMN 307 WITH FDA IN SECOND HALF OF 2019.  Full Article

Biomarin Pharmaceutical Q3 GAAP Loss Per Share $0.07
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN ANNOUNCES THIRD QUARTER 2018 RESULTS.Q3 GAAP LOSS PER SHARE $0.07.Q3 REVENUE $391.7 MILLION VERSUS I/B/E/S VIEW $367.1 MILLION.Q3 EARNINGS PER SHARE VIEW $-0.22 -- THOMSON REUTERS I/B/E/S.BIOMARIN PHARMACEUTICAL - AS OF SEPT 30, 2018, HAD CASH, CASH EQUIVALENTS & INVESTMENTS TOTALING ABOUT $1.6 BILLION, COMPARED TO $1.8 BILLION ON DEC 31, 2017.BIOMARIN PHARMACEUTICAL -SEES FY 2018 TOTAL REVENUES $1,470 MILLION TO $1,530 MILLION.SEES FY 2018 GAAP NET LOSS $115 MILLION TO $165 MILLION.BIOMARIN PHARMACEUTICAL -SEES FY 2018 NON-GAAP INCOME $100 MILLION TO $140 MILLION.  Full Article

Biomarin Pharmaceutical Says On Oct 19, Co Entered Into A Credit Agreement
Tuesday, 23 Oct 2018 

Oct 23 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN PHARMACEUTICAL INC - ON OCTOBER 19, CO ENTERED INTO A CREDIT AGREEMENT - SEC FILING.BIOMARIN PHARMACEUTICAL INC - CREDIT AGREEMENT PROVIDES FOR UP TO $200 MILLION IN REVOLVING LOANS.BIOMARIN PHARMACEUTICAL INC - REVOLVING CREDIT FACILITY MATURES ON OCTOBER 19, 2021.  Full Article

BioMarin Receives $20 Mln In Milestone Payments From Pfizer For Talazoparib
Thursday, 7 Jun 2018 

June 7 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES MILESTONE PAYMENTS FROM PFIZER FOR TALAZOPARIB.BIOMARIN PHARMACEUTICAL INC - COMPANY RECEIVED $20 MILLION IN MILESTONE PAYMENTS FROM PFIZER INC.BIOMARIN PHARMACEUTICAL INC - MILESTONE PAYMENTS ARE PART OF AGREEMENT MADE WITH MEDIVATION, INC. WHEN CO PURCHASED TALAZOPARIB.BIOMARIN PHARMA - MILESTONE PAYMENTS TRIGGERED BY U.S. FDA ACCEPTANCE OF PFIZER'S NEW DRUG APPLICATION (NDA) SUBMISSION FOR TALAZOPARIB.BIOMARIN PHARMA - MILESTONE PAYMENTS ALSO TRIGGERED BY EUROPEAN MEDICINES AGENCY ACCEPTANCE OF PFIZER'S SUBMISSION OF MAA FOR TALAZOPARIB.  Full Article

Biomarin Receives Standard Approval For Palynziq For Treatment Of Rare Genetic Disease
Thursday, 24 May 2018 

May 24 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES STANDARD APPROVAL FOR PALYNZIQ™ (PEGVALIASE-PQPZ) INJECTION FOR TREATMENT OF ADULTS WITH PHENYLKETONURIA (PKU), A RARE GENETIC DISEASE.BIOMARIN PHARMACEUTICAL INC - PALYNZIQ IS EXPECTED TO BE AVAILABLE IN UNITED STATES BY END OF JUNE.  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