BioMarin Pharmaceutical Inc. Class Action Lawsuit
- Company Name
- BioMarin Pharmaceutical Inc.
- Stock Symbol
- Class Period
- February 28, 2020 to August 18, 2020
- 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.
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