BioMarin Pharmaceutical

BioMarin Pharmaceutical, Inc. engages in the development and commercialization of therapies for people with serious and life-threatening rare diseases and medical conditions. Its pipeline products include Valoctocogene roxaparvovec, Vosoritide, and BMN 307. The company was founded by John C. Klock, Christopher M. Starr and Grant W. Denison on March 21, 1997, and is headquartered in San Rafael, CA.

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BioMarin excels in Q4 with record revenues and gene therapy launch

BioMarin Pharmaceutical reported strong financial results in Q4 2022, achieving revenue growth, profitability, and successful introduction of the ROCTAVIAN gene therapy for hemophilia A.
The company's performance highlights its R&D capabilities, market positioning, and strategic readiness for upcoming product launches, positioning BioMarin for continued growth and innovation.
While facing challenges in reimbursement processes and regulatory requirements, BioMarin has opportunities to drive revenue expansion, market penetration, and address unmet medical needs through its innovative pipeline.

BioMarin reports strong Q1 earnings, eyes blockbuster status for ROCTAVIAN

BioMarin Pharmaceuticals had a robust Q1 2023, focusing on revenue growth, profitability, and commercial readiness for key drug launches. While facing challenges in Germany, the company is optimistic about the potential of ROCTAVIAN and VOXZOGO in driving future growth.

BioMarin excels in Q2 with record revenues and treatment milestones

BioMarin's strong Q2 performance, driven by record revenues and product demand, positions the company for growth.
Challenges like supply issues and site readiness are being addressed, while opportunities in new programs and markets are promising.
Overall, BioMarin's focus on compliance, expansion, and pipeline development sets a positive trajectory for future success.

BioMarin reports strong Q3 revenue growth, eyes Roctavian expansion

BioMarin's Q3 performance showed revenue growth driven by Voxzogo, with strong expectations for 2024 revenue.
New CEO Alexander Hardy is set to continue the core strategy, focusing on Roctavian's global launch and Voxzogo's growth potential.
Challenges include delays in Roctavian's takeoff and supply constraints for Voxzogo, but efforts are underway to address these issues.
Opportunities lie in Roctavian's revenue contribution, Voxzogo's U.S. growth potential, and leveraging CNP for stature improvements.

BioMarin posts robust Q4 earnings, eyes expansion in gene therapy

BioMarin Pharmaceutical delivered strong financial results in Q4 2023, driven by revenue growth and increased earnings per share. The company's focus on high-impact medicines and gene therapy expertise positions it well for future growth.
While facing challenges related to analyst inquiries and market adoption of key products like Roctavian and Voxzogo, BioMarin remains committed to innovation and optimizing its business model.
Opportunities lie in expanding product reach, maximizing shareholder value through strategic capital allocation, and driving innovation in transformative programs. BioMarin's long-term strategy and growth potential remain promising.

BioMarin reports record revenue, focuses on key assets for growth

BioMarin Pharmaceutical's Q1 2024 performance reflects strong revenue growth and financial stability, driven by key product demand.
While facing challenges such as revenue impact and supply constraints, the company's strategic focus on key assets and cost reduction initiatives bode well for future growth.
Opportunities lie in expanding Voxzogo's market reach, optimizing manufacturing capabilities, and maintaining a competitive edge in innovative treatments.

BioMarin Pharmaceuticals reports record revenue and profitability outlook for 2024

BioMarin Pharmaceuticals delivered strong financial performance in Q2 2024, driven by robust revenue growth and strategic decisions. The company's focus on profitability, expansion of key treatments, and progress in R&D highlight a promising outlook. Addressing analyst inquiries and leveraging upcoming events can further enhance investor confidence and market positioning.

BioMarin reports record Q3 revenues, eyes long-term growth targets

BioMarin Pharmaceuticals showcased robust financial performance and raised full-year guidance.
The company remains optimistic about its long-term growth prospects and is committed to defending its IP.
Strategic focus on expanding global reach and driving growth in enzyme therapies portfolio.

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BioMarin Pharmaceutical Inc (NASDAQ: BMRN) has announced new data from open-label Phase 1/2 trial of valoctocogene roxaparvovec, an investigational gene therapy candidate for severe hemophilia A. Data were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress.

BioMarin Shares 5-Year Data From Open-Label Trial Of Hemophilia Gene Therapy

SAN RAFAEL, Calif., July 21, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today new data for valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A, from its open-label Phase 1/2 study during an oral presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress.

BioMarin Announces Oral Presentation at International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress with 5 Years of Clinical Data from Ongoing Phase 1/2 Study of Valoctocogene Roxaparvovec in Adults with Severe Hemophilia A, Demonstra

SAN RAFAEL, Calif., July 19, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced new data for valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A, in its positive pivotal study, GENEr8-1, during an oral presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress.

BioMarin Announces Oral Presentation of Positive One-Year Results from Phase 3 Pivotal Trial with Valoctocogene Roxaparvovec Gene Therapy in Adults with Severe Hemophilia A at International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congres

The EMA validates BioMarin's (BMRN) marketing application for valoctocogene roxaparvovec to treat adult patients with severe hemophilia A.

BioMarin (BMRN) Gets EMA Validation for Hemophilia Gene Therapy

The European Medicines Agency (EMA) has validated BioMarin Pharmaceutical Inc's (NASDAQ: BMRN) marketing application seeking approval for hemophilia A gene therapy, valoctocogene roxaparvovec. With today's validation, the application review can now commence.

BioMarin Expects EMA's CHMP Opinion In 1H 2022 For Its Hemophilia A Gene Therapy, FDA Resubmission In 2Q'22

SAN RAFAEL, Calif., July 15, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.

European Medicines Agency Validates BioMarin's Marketing Authorization Application for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A

SAN RAFAEL, Calif., July 14, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, July 28, at 4:30 p.m.

BioMarin to Host Second Quarter 2021 Financial Results Conference Call and Webcast on Wednesday, July 28 at 4:30pm ET

SAN RAFAEL, Calif., July 2, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced three oral presentations and nine poster presentations related to valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A, at the International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress being held July 17-21, 2021.

BioMarin Announces 12 Presentations at the International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress

Biomarin Pharmaceutical's (BMRN) new MAA in EU includes 52 weeks' data from the phase III GENEr8-1 study, along with four and three-year follow-up data from the ongoing phase I/II dose escalation study.

BioMarin (BMRN) Re-Files MAA for Hemophilia Gene Therapy in EU

Biomarin Pharmaceutical (BMRN) receives positive recommendation from Europe's CHMP for vosoritide to treat achondroplasia in children.

BioMarin's (BMRN) Vosoritide Gets CHMP Nod to Treat Dwarfism

SAN RAFAEL, Calif., June 28, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the company resubmitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.

BioMarin Resubmits Marketing Authorization Application (MAA) to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A

European Medical Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of BioMarin Pharmaceutical Inc (NASDAQ: BMRN) vosoritide for achondroplasia in children aged two years and above until growth plates are closed, which occurs after puberty. Achondroplasia is the most common form of disproportionate short stature in humans.

EMA's Advisory Committee Backs Approval Of BioMarin's Dwarfism Candidate

SAN RAFAEL, Calif., June 25, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for vosoritide, a once daily injection analog of C-type Natriuretic Peptide (CNP) to treat achondroplasia in children from the age of 2 until growth plates are closed, which occurs after puberty when children reach final adult height.

BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close

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SAN RAFAEL, Calif., June 15, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that management will participate in the BofA Securities 2021 Napa Biopharma Conference on June 16, 2021 at 3:30pm ET.

BioMarin to Participate in the Virtual BofA Securities 2021 Napa Biopharma Conference

BioMarin product revenue has begun to decline. The outlook and guidance for 2021 is consistent with the modest decline reported in the first quarter. The next catalyst is likely November 2021 which is the scheduled PDUFA date for Vosoritide.

BioMarin: Too Soon To Buy

BioMarin stock remains depressed since the August CRL. There are major catalysts ahead.

BioMarin: Depressed Price Due To CRL, Major Catalysts Ahead

The EMA grants accelerated assessment to BioMarin's (BMRN) request for review of valoctocogene roxaparvovec for treating severe hemophilia A.

BioMarin (BMRN) Hemophilia Gene Therapy Gets EMA's Speedy Review

We believe that BioMarin Pharmaceutical stock is a good buying opportunity at the present time. BMRN stock trades near $78 currently and it is, in fact, down 19% from its pre-Covid high of around $97 in March 2020 – before the coronavirus pandemic hit the world.

Should You Buy BioMarin Pharmaceutical Stock At $78?

The European Medicines Agency (EMA) has granted its request for accelerated assessment review to BioMarin Pharmaceutical Inc's (NASDAQ: BMRN) valoctocogene roxaparvovec, gene therapy to treat severe hemophilia A, with an opinion expected in the first half of 2022, the company said. With the EMA agreeing to give the therapy a closer look, BioMarin said it plans to submit an associated marketing application by June, based on Phase 3 data that includes one-year follow-up results and four and three years of follow-up from an ongoing Phase 1/2 dose-escalation study.

EMA Grants BioMarin's Request For Speedy Review of Hemophilia A Gene Therapy

SAN RAFAEL, Calif., May 24, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) has granted its request for accelerated assessment of valoctocogene roxaparvovec, for adults with severe hemophilia A.

European Medicines Agency Grants BioMarin's Request for Accelerated Assessment of Valoctocogene Roxaparvovec for Treatment of Severe Hemophilia A

BioMarin Pharmaceutical Inc (NASDAQ: BMRN) has announced an update to its previously reported results from Phase 1/2 study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A. Data will be shared at the International Society on Thrombosis and Haemostasis 2021 Virtual Congress to be held in July.

Five-Year Data Of BioMarin's Hemophilia Gene Therapy Shows Sustained Benefit

SAN RAFAEL, Calif., May 19, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today an update to its previously reported results from an open-label Phase 1/2 study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A.

BioMarin Provides Highlights of 5 Years of Clinical Data from Ongoing Phase 1/2 Study of Valoctocogene Roxaparvovec with the Longest Duration of Clinical Experience for a Gene Therapy in Hemophilia A

SAN RAFAEL, Calif., May 12, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced three oral and three poster presentations on valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A at the American Society of Gene and Cell Therapy (ASGCT) Virtual 2021 Annual Meeting being held May 11-14.

BioMarin Announces 6 Presentations at American Society of Gene and Cell Therapy (ASGCT) Virtual 2021 Annual Meeting

BioMarin (BMRN) beats estimates for both earnings and revenues in the first quarter of 2021.

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