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BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) delivers innovative therapies for rare genetic disorders through advanced biotechnology research. This news hub provides investors and healthcare professionals with timely updates on regulatory milestones, clinical trial progress, and strategic initiatives shaping the future of genetic medicine.
Access the most comprehensive collection of BioMarin news, including updates on enzyme replacement therapies, gene therapy advancements, and global commercialization efforts. Our curated feed ensures you stay informed about pipeline developments, partnership announcements, and financial performance without promotional bias.
Key updates cover FDA/EMA regulatory decisions, quarterly earnings insights, research collaborations, and manufacturing expansions. All content is verified through primary sources to maintain accuracy and compliance with financial disclosure standards.
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BioMarin Pharmaceutical announced the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for valoctocogene roxaparvovec, a gene therapy for severe hemophilia A. This initiates the review process, with a CHMP opinion expected in the first half of 2022. The MAA includes data from the Phase 3 GENEr8-1 study involving 134 participants. The EMA previously granted an accelerated assessment for this application, highlighting its public health significance. BioMarin plans to resubmit its Biologics License Application (BLA) in the U.S. in Q2 2022.
BioMarin Pharmaceutical Inc. (BMRN) will host a conference call and webcast on July 28, 2021, at 4:30 p.m. ET to discuss its second quarter financial results. The call will be led by Jean-Jacques Bienaimé, Chairman and CEO. Investors can access the live audio via BioMarin's investor website, with a replay available for one week post-call. As a biotechnology company, BioMarin focuses on innovative therapies for serious genetic diseases, holding a portfolio of six commercial products and multiple candidates under development.
BioMarin Pharmaceutical (NASDAQ: BMRN) announced 12 presentations related to valoctocogene roxaparvovec, a gene therapy for severe hemophilia A, at the ISTH 2021 Virtual Congress from July 17-21, 2021. This includes significant findings from the Phase 3 GENEr8-1 trial, which is the largest gene therapy trial for hemophilia A, showing prolonged hemostatic efficacy. BioMarin resubmitted a Marketing Authorization Application to the EMA on June 25, 2021, with a CHMP opinion expected in H1 2022, and plans for a BLA resubmission to FDA in Q2 2022.
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) has resubmitted a Marketing Authorization Application (MAA) for its gene therapy, valoctocogene roxaparvovec, targeting adults with severe hemophilia A. The European Medicines Agency (EMA) granted the request for accelerated assessment, potentially expediting the review process. The application includes data from the 134 participants in the Phase 3 GENEr8-1 study. A CHMP opinion is expected in H1 2022, while a Biologics License Application (BLA) resubmission is planned for Q2 2022 in the U.S., contingent on favorable results.
BioMarin Pharmaceutical has received a positive opinion from the CHMP for vosoritide, a treatment for achondroplasia in children aged 2 until growth plates close. A final approval from the European Commission is anticipated in Q3 2021. Over 11,000 children in Europe, the Middle East, and Africa may benefit from this first pharmacological option. The French health authority has granted temporary authorization for immediate access to vosoritide. The treatment has shown promising safety and efficacy outcomes in clinical studies, with no serious adverse events linked to the drug.
BioMarin Pharmaceutical (NASDAQ: BMRN) will present at the BofA Securities 2021 Napa Biopharma Conference on June 16, 2021, at 3:30 PM ET. An audio webcast of the presentation will be available live, with an archived version accessible on the company's website for a limited time afterwards. BioMarin focuses on developing therapies for rare disorders and has a diverse portfolio of six commercialized products alongside several clinical candidates. For more details, visit www.biomarin.com.
BioMarin Pharmaceutical announced its participation in two virtual investor conferences on May 27, 2021. An audio webcast of the presentations will be available live through the company's investor relations website. Additionally, an archived version of the remarks will be accessible for a limited time after the conferences. BioMarin, a global biotechnology company, specializes in innovative therapies for serious rare disorders and has a portfolio of six commercial products alongside multiple clinical candidates. For more details, visit www.biomarin.com.
BioMarin Pharmaceutical (NASDAQ: BMRN) announced that the European Medicines Agency (EMA) has granted accelerated assessment for valoctocogene roxaparvovec, aimed at treating adults with severe hemophilia A. This expedited review process is expected to shorten the evaluation timeline, with a Committee for Medicinal Products for Human Use (CHMP) opinion anticipated in the first half of 2022. BioMarin plans to submit a Marketing Authorization Application (MAA) in June 2021, including 52 weeks of Phase 3 GENEr8-1 trial data.
BioMarin Pharmaceutical has shared a significant update regarding its investigational gene therapy valoctocogene roxaparvovec for severe hemophilia A. The latest data shows sustained treatment benefits over five years, with participants remaining off prophylactic Factor VIII treatment. The mean annualized bleed rate in year five was 0.7, representing a 95% reduction from baseline. The company plans to submit a Marketing Authorization Application in Europe in June 2021 and a Biologics License Application in the U.S. in Q2 2022, contingent on favorable study results.
BioMarin Pharmaceutical (NASDAQ: BMRN) announced participation in two virtual conferences, with live audio webcasts available for investors. The webcasts can be accessed at biomarin.com. An archived version will also be accessible post-conference. BioMarin focuses on developing therapies for rare disorders, boasting a portfolio of six commercial products and various clinical candidates. For more details, visit their website.
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