We are investigating BioMarin Pharmaceutical Inc. (BMRN) (“BioMarin” or the “Company”) for potential violations of the federal securities laws. On August 19, 2020, BioMarin announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) to the Company’s Biologics License Application for valoctocogene roxaparvovec gene therapy for severe hemophilia A. BioMarin advised investors that in the CRL, “the FDA introduced a new recommendation for two years of data from the Company’s ongoing 270-301 study (Phase 3) to provide substantial evidence of a durable effect using Annualized Bleeding Rate (ABR) as the primary endpoint” and “recommended that the Company complete the Phase 3 Study and submit two-year follow-up safety and efficacy data on all study participants.” On this news, BioMarin’s stock price fell sharply during intraday trading on August 19, 2020.