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Biomarin Pharmaceutical Inc (BMRN.OQ)

BMRN.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

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 reports Q3 loss $0.07/shr
Friday, 27 Oct 2017 

Oct 26 (Reuters) - Biomarin Pharmaceutical Inc :Biomarin announces third quarter 2017 financial results.Q3 GAAP loss per share $0.07.Q3 earnings per share view $-0.14 -- Thomson Reuters I/B/E/S.Sees FY 2017 revenue $1.29 billion to $1.32 billion.Q3 revenue $334.1 million versus I/B/E/S view $347.4 million.FY2017 revenue view $1.31 billion -- Thomson Reuters I/B/E/S.Biomarin Pharmaceutical Inc sees ‍ full-year non-GAAP income $60 million to $80 million ​.Biomarin Pharmaceutical Inc sees ‍full-year GAAP net loss $110 to $130​.  Full Article

FDA grants Breakthrough Therapy Designation for BioMarin's gene therapy for hemophilia A
Thursday, 26 Oct 2017 

Oct 26 (Reuters) - BioMarin Pharmaceutical Inc :FDA grants Breakthrough Therapy Designation for BioMarin's valoctocogene roxaparvovec (formerly BMN 270), an investigational gene therapy for hemophilia A.BioMarin Pharmaceutical Inc - ‍BioMarin expects to initiate enrollment of a global Phase 3 program before end of year​.  Full Article

Biomarin begins phase 3 trial for treatment for children with achondroplasia
Monday, 12 Dec 2016 

Biomarin Pharmaceutical Inc : Biomarin Pharmaceutical says in addition, Biomarin is planning a separate phase 2 study evaluating effect of Vosoritide in infants and toddlers .Biomarin enrolls first participant in phase 3 trial of vosoritide for treatment of children with Achondroplasia.  Full Article

BioMarin announces update to Brineura program
Wednesday, 7 Sep 2016 

BioMarin Pharmaceutical Inc : BioMarin announces update to Brineura (cerliponase alfa) program for treatment of CLN2 disease, a form of batten disease . Additional data submitted to BLA following FDA request, PDUFA action date extended to April 27, 2017 . Additional 8 months of treatment (81-week data) show maintenance of efficacy, consistent with previously submitted 48-week data .FDA has not communicated their rationale for declaring submission a major amendment.  Full Article

Biomarin Pharmaceutical announces pricing of public offering of common stock
Tuesday, 9 Aug 2016 

Biomarin Pharmaceutical Inc : Biomarin announces pricing of public offering of common stock .Says public offering of 7.50 million common shares priced at $96.00per share.  Full Article

Biomarin Pharmaceutical files for potential mixed shelf offering
Tuesday, 9 Aug 2016 

Biomarin Pharmaceutical Inc :Files for potential mixed shelf offering; size not disclosed - SEC filing.  Full Article

Biomarin says offering of 7.5 mln shares of stock
Tuesday, 9 Aug 2016 

Biomarin Pharmaceutical Inc : Biomarin announces public offering of common stock .Says offering of 7.5 million shares of its common stock in an underwritten public offering.  Full Article

Biomarin Pharmaceutical Q2 GAAP loss per share $2.61
Friday, 5 Aug 2016 

Biomarin Pharmaceutical Inc : Biomarin announces second quarter 2016 financial results . Sees FY 2016 revenue $1.10 billion - $1.15 billion . Q2 GAAP loss per share $2.61 . Q2 earnings per share view $-0.52 -- Thomson Reuters I/B/E/S . Q2 revenue $300.1 million versus i/b/e/s view $278.2 million .FY2016 revenue view $1.09 billion -- Thomson Reuters I/B/E/S.  Full Article

BRIEF-Biomarin Receives Anticipated Notification Of PDUFA Extension For Pegvaliase Biologics License Application

* BIOMARIN RECEIVES ANTICIPATED NOTIFICATION OF PDUFA EXTENSION FOR PEGVALIASE BIOLOGICS LICENSE APPLICATION (BLA) TO MAY 28, 2018