|Company name||BioMarin, Inc.|
|Status||Class Action Complaint Filed|
NEW YORK, October 14, 2020 –Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of investors that purchased BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) securities between February 28, 2020 and August 18, 2020 (the “Class Period”). Investors have until November 24, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
BioMarin was founded in 1996 and is headquartered in San Rafael, California. BioMarin is a biotechnology company that develops and commercializes therapies for people with serious and life-threatening rare diseases and medical conditions. The Company’s product candidates include, among others, valoctocogene roxaparvovec, an investigational adenoassociated virus (“AAV”) gene therapy, which is in Phase 3 clinical development for the treatment of patients with severe hemophilia A.
On August 19, 2020, BioMarin announced receipt of a Complete Response Letter (“CRL”) from the FDA to the Company’s Biologics License Application (“BLA”) for valoctocogene roxaparvovec. 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.” In explaining the new recommendation, 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.”
On this news, BioMarin’s stock price fell $41.82 per share, or 35.28%, to close at $76.72 per share on August 19, 2020.
The complaint, filed on September 25, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) differences between the Phase 1/2 and Phase 3 study of valoctocogene roxaparvovec limited the reliability of the Phase 1/2 study to support valoctocogene roxaparvovec’s durability of effect; (ii) as a result, it was foreseeable that the FDA would not approve the BLA for valoctocogene roxaparvovec without additional data; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased BioMarin securities during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, or telephone at (212) 355-4648, or by filling out the contact form below. There is no cost or obligation to you.