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Biomarin Pharmaceutical Inc (BMRN.OQ)

BMRN.OQ on NASDAQ Stock Exchange Global Select Market

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22 Sep 2020
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Latest Key Developments (Source: Significant Developments)

Biomarin Receives Complete Response Letter From FDA For Valoctocogene Roxaparvovec Gene Therapy
Wednesday, 19 Aug 2020 

Aug 19 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES COMPLETE RESPONSE LETTER (CRL) FROM FDA FOR VALOCTOCOGENE ROXAPARVOVEC GENE THERAPY FOR SEVERE HEMOPHILIA A.BIOMARIN - FDA INTRODUCES NEW RECOMMENDATION FOR 2-YEAR ANNUALIZED BLEEDING RATE (ABR) AS PRIMARY ENDPOINT FOR ONGOING PHASE 3 STUDY 270-301.BIOMARIN - FDA CONCLUDED, DIFFERENCES BETWEEN STUDY 270-201 & PHASE 3 STUDY LIMITED ABILITY TO RELY ON PHASE 1/2 STUDY TO SUPPORT DURABILITY OF EFFECT.  Full Article

Biomarin Says Extends Gene Therapy Leadership With Dinaqor In Preclinical Collaboration And License Agreement To Develop Gene Therapies For Rare Genetic Cardiomyopathies
Monday, 4 May 2020 

May 3 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN EXTENDS GENE THERAPY LEADERSHIP WITH DINAQOR IN A PRECLINICAL COLLABORATION AND LICENSE AGREEMENT TO DEVELOP GENE THERAPIES FOR RARE GENETIC CARDIOMYOPATHIES.BIOMARIN PHARMACEUTICAL - COMPANY DID NOT DISCLOSE FINANCIAL TERMS.BIOMARIN PHARMACEUTICAL INC - MANAGEMENT REITERATED ITS 2020 GAAP NET INCOME GUIDANCE OF $20 TO $80 MILLION, INCLUSIVE OF THIS COLLABORATION.BIOMARIN PHARMACEUTICAL - PRECLINICAL COLLABORATION,LICENSE DEAL WITH DINAQOR TO DEVELOP NOVEL GENE THERAPIES TO TREAT RARE GENETIC CARDIOMYOPATHIES.BIOMARIN PHARMACEUTICAL INC - LICENSE INITIALLY COVERS DINAQOR'S LEAD PROGRAM, DINA-001 FOR MYBPC3 HYPERTROPHIC CARDIOMYOPATHY (HCM).  Full Article

Biomarin Submits Biologics License Application To U.S. FDA For Valoctocogene Roxaparvovec To Treat Hemophilia A
Monday, 23 Dec 2019 

Dec 23 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN SUBMITS BIOLOGICS LICENSE APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR VALOCTOCOGENE ROXAPARVOVEC TO TREAT HEMOPHILIA A.BIOMARIN PHARMACEUTICAL INC - WILL PROVIDE AN UPDATE IN FEBRUARY 2020.BIOMARIN PHARMACEUTICAL- SUBJECT TO COMPLETION OF FDA'S FILING REVIEW, BIOMARIN ANTICIPATES BLA REVIEW TO COMMENCE IN FEB 2020.  Full Article

Biomarin says Valoctocogene Roxaparvovec On Track For U.S., EU Regulatory Submissions By Year End
Thursday, 14 Nov 2019 

Nov 14 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN PHARMACEUTICAL - GUIDANCE OF GAAP NET INCOME BREAK-EVEN OR BETTER IN 2020, IF VALOCTOCOGENE ROXAPARVOVEC COMMERCIALLY LAUNCHED IN 2H 2020.BIOMARIN PHARMACEUTICAL INC - VALOCTOCOGENE ROXAPARVOVEC ON TRACK FOR US AND EU REGULATORY SUBMISSIONS BY YEAR END.BIOMARIN PHARMACEUTICAL - VOSORITIDE SUSTAINS HEIGHT GAIN IN PHASE 2 STUDY, PHASE 3 TOPLINE RESULTS EXPECTED BY YEAR END.  Full Article

BRIEF-Biomarin Pharmaceutical Reports Qtrly Earnings Per Share Of $0.30 (Oct.23)
Thursday, 24 Oct 2019 

Corrects headline and third bullet to say the company reported qtrly earnings per share and not loss per share:BIOMARIN ANNOUNCES THIRD QUARTER 2019 FINANCIAL RESULTS.Q3 REVENUE $461.1 MILLION VERSUS REFINITIV IBES ESTIMATE OF $454.5 MILLION.QTRLY EARNINGS PER SHARE $0.30.BIOMARIN PHARMACEUTICAL - AS OF SEPT 30, 2019, HAD CASH, CASH EQUIVALENTS AND INVESTMENTS TOTALING ABOUT $1.2 BILLION, VERSUS $1.3 BILLION ON DECEMBER 31, 2018.Q3 EARNINGS PER SHARE VIEW $0.06 -- REFINITIV IBES DATA.  Full Article

Biomarin Posts Q2 Net Loss Per Share Of $0.21
Friday, 2 Aug 2019 

Aug 1 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS.Q2 REVENUE $387.8 MILLION VERSUS REFINITIV IBES ESTIMATE OF $414.4 MILLION.SEES FY 2019 REVENUE $1.68 BILLION TO $1.75 BILLION.QTRLY GAAP NET LOSS PER SHARE $0.21.Q2 EARNINGS PER SHARE VIEW $-0.10 -- REFINITIV IBES DATA.FULL-YEAR 2019 FINANCIAL GUIDANCE REMAINS UNCHANGED.  Full Article

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 Earns Milestone Payments From Pfizer
Friday, 21 Jun 2019 

June 21 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN EARNS MILESTONE PAYMENTS FROM PFIZER FOR TALZENNA® (TALAZOPARIB) FOR METASTATIC BREAST CANCER PATIENTS WITH AN INHERITED BRCA MUTATION.BIOMARIN PHARMACEUTICAL INC - EUROPEAN COMMISSION APPROVAL TRIGGERS $15 MILLION PAYMENT.BIOMARIN PHARMACEUTICAL INC - BIOMARIN ENTITLED TO EARN MID-SINGLE DIGIT ROYALTIES ON FUTURE SALES.BIOMARIN PHARMACEUTICAL INC - COMPANY EARNED A $15 MILLION MILESTONE PAYMENT FROM PFIZER.BIOMARIN PHARMACEUTICAL INC - $15 MILLION MILESTONE PAYMENT WAS TRIGGERED BY EUROPEAN COMMISSION APPROVAL OF TALZENNA.  Full Article

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
Friday, 22 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

U.S. FDA rejects BioMarin hemophilia A gene therapy, shares dive

The U.S. Food and Drug Administration rejected BioMarin Pharmaceutical Inc's gene therapy for bleeding disorder hemophilia A citing the need for longer-term data, the drugmaker said on Wednesday, potentially pushing any approval out to 2022.