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Biomarin Pharmaceutical Inc (BMRN.OQ)

BMRN.OQ on NASDAQ Stock Exchange Global Select Market

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15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Biomarin Sells Second Priority Review Voucher For $125 Mln
Monday, 27 Nov 2017 08:45am EST 

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
Thursday, 26 Oct 2017 04:05pm EDT 

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 08:30am EDT 

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 presents interim data of phase 1/2 study of BMN 250 for treatment of Sanfilippo B syndrome
Wednesday, 6 Sep 2017 11:00am EDT 

Sept 6 (Reuters) - Biomarin Pharmaceutical Inc :Biomarin presents interim data of phase 1/2 study of BMN 250 for treatment of Sanfilippo B syndrome (MPS IIIB) at 13th international congress of inborn errors of metabolism (ICIEM) 2017.Says ‍interim trial data indicates that ICV-administered bmn 250 was well-tolerated by Sanfilippo B patients​.  Full Article

FDA accepts Biomarin's Pegvaliase Biologics License Application
Tuesday, 29 Aug 2017 04:05pm EDT 

Aug 29 (Reuters) - Biomarin Pharmaceutical Inc :FDA accepts Biomarin's Pegvaliase Biologics License Application (bla) and grants priority review designation.Biomarin Pharmaceutical Inc - ‍PDUFA action date is February 28, 2018​.Biomarin Pharmaceutical Inc - ‍FDA has requested additional Chemistry, Manufacturing, and Controls (CMC) information for Pegvaliase​.Biomarin - ‍When additional information is submitted to FDA, it will be classified as major amendment and result in 3 month extension of PDUFA date​.Biomarin Pharmaceutical Inc - FDA has not informed company whether an advisory committee meeting to discuss pegvaliase​ application will be needed.  Full Article

BioMarin announces offering of $450 mln of 0.599 pct senior convertible notes
Monday, 7 Aug 2017 08:04pm EDT 

Aug 7 (Reuters) - BioMarin Pharmaceutical Inc -:BioMarin announces offering of $450 million of 0.599% senior subordinated convertible notes due 2024.BioMarin - to use majority of net proceeds to repay, repurchase or settle in cash some or all of co's 0.75% senior subordinated notes due in October 2018.  Full Article

Biomarin announces offering of $450 mln of senior subordinated convertible notes due 2024
Monday, 7 Aug 2017 04:01pm EDT 

Aug 7 (Reuters) - Biomarin Pharmaceutical Inc :Biomarin announces offering of $450 million of senior subordinated convertible notes due 2024.Biomarin- to use majority of proceeds from offering to repay, repurchase or settle in cash co's 0.75% senior subordinated convertible notes due in Oct 2018​.  Full Article

Sarepta and Biomarin report execution of global settlement
Tuesday, 18 Jul 2017 08:30am EDT 

July 18 (Reuters) - Sarepta Therapeutics Inc ::Sarepta Therapeutics and Biomarin Pharmaceutical Inc. Announce execution of a global settlement and a license agreement resolving exon skipping patent litigation.Sarepta Therapeutics Inc - ‍under terms of license and settlement agreements, Sarepta will make a one-time payment of $35 million to Biomarin​.Says ‍Sarepta will also pay royalties to Biomarin​.Sarepta- ‍Biomarin retains right to convert license to a co-exclusive right in event it decides to proceed with an exon-skipping therapy for dmd​.Sarepta Therapeutics- ‍Biomarin retains right to convert license to co-exclusive right in event it decides to proceed with exon-skipping therapy for DMD​.Sarepta Therapeutics - to make ‍additional regulatory, commercial milestone payments for exons 51, 45, 53, possibly on future exon-skipping products.Sarepta-‍effectiveness of agreements subject to closing conditions including execution of necessary approvals by Academisch Ziekenhuis Leiden by July 24​.  Full Article

BioMarin submits pegvaliase Biologics License Application to the U.S. FDA for treatment of phenylketonuria
Friday, 30 Jun 2017 09:10am EDT 

June 30 (Reuters) - BioMarin Pharmaceutical Inc :BioMarin submits pegvaliase biologics license application (BLA) to the U.S. FDA for treatment of phenylketonuria (PKU).BioMarin Pharmaceutical Inc - ‍company also intends to submit an application for registration in European Union (EU) by year end 2017​.  Full Article

Biomarin Pharmaceutical says European commission approves Brineura as first treatment for CLN2 disease
Thursday, 1 Jun 2017 08:31am EDT 

June 1 (Reuters) - Biomarin Pharmaceutical Inc ::European commission approves Brineura (cerliponase alfa), the first treatment for cln2 disease, a form of batten disease and ultra-rare brain disorder in children.Biomarin Pharmaceutical Inc says dosing administration includes all ages from birth.  Full Article