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BioMarin Pharmaceutical Inc. Class Action Lawsuit

27 days left to seek lead plaintiff status

Case Summary

Company Name
BioMarin Pharmaceutical Inc.
Stock Symbol
BMRN
Class Period
February 28, 2020 to August 18, 2020
Motion Deadline
November 24, 2020
Court
Northern District of California

The BioMarin Pharmaceutical Inc. class action lawsuit charges BioMarin and certain of its executives with violations of the Securities Exchange Act of 1934 and seeks to represent purchasers or acquirers of BioMarin securities between February 28, 2020 and August 18, 2020, inclusive (the “Class Period”).  The BioMarin class action lawsuit was commenced on September 25, 2020 in the Northern District of California and is captioned Tsantes v. BioMarin Pharmaceutical Inc., No. 20-cv-06719.

BioMarin is a biotechnology company that develops and commercializes therapies for people with serious and life-threatening rare diseases and medical conditions.  BioMarin’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.

The BioMarin class action lawsuit alleges that during the Class Period 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 U.S. Food and Drug Administration would not approve the Biologics License Application (“BLA”) for valoctocogene roxaparvovec without additional data; and (iii) as a result, BioMarin’s public statements were materially false and misleading at all relevant times.

On August 19, 2020, BioMarin announced receipt of a Complete Response Letter (“CRL”) from the FDA to BioMarin’s 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 more than 35%, damaging investors.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased BioMarin securities during the Class Period to seek appointment as lead plaintiff in the BioMarin class action lawsuit.  A lead plaintiff will act on behalf of all other class members in directing the BioMarin class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the BioMarin class action lawsuit.  An investor’s ability to share in any potential future recovery of the BioMarin class action lawsuit is not dependent upon serving as lead plaintiff.  If you wish to serve as lead plaintiff of the BioMarin class action lawsuit or have questions concerning your rights regarding the BioMarin class action lawsuit, please provide your information here or contact counsel, Michael Albert of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at malbert@rgrdlaw.com.  Lead plaintiff motions for the BioMarin class action lawsuit must be filed with the court no later than November 24, 2020.

Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation.  With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history.  For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements.  Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims.  Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide.  Robbins Geller attorneys are consistently recognized by courts, professional organizations and the media as leading lawyers in the industry.

Class Period: February 28, 2020 - August 18, 2020
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