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BioMarin Pharmaceuticals Inc.

Company NameBioMarin Pharmaceuticals Inc.
Stock SymbolBMRN
Class PeriodFebruary 28, 2020 to August 18, 2020
Lead Plaintiff Motion DeadlineNovember 24, 2020

On August 19, 2020, BioMarin announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s Biologics License Application (“BLA”) for valoctocogene roxaparvovec. Therein, the FDA concluded that the “differences between Study 270-201 (Phase 1/2) and the Phase 3 study limited its ability to rely on the Phase 1/2 study to support durability of effect.” As a result, the FDA recommended that BioMarin “complete the Phase 3 Study and submit two-year follow-up safety and efficacy data on all study participants.”

 

On this news, the Company’s stock price fell $41.82 per share, or 35%, to close at $76.72 per share on August 19, 2020, thereby injuring investors.

 

 

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