NEW YORK, Oct. 17, 2020 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against BioMarin Pharmaceuticals, Inc. ("BioMarin" or the "Company") (NASDAQ: BMRN) and certain of its officers. The class action, filed in United States District Court for the Northern District of California, and docketed under 20-cv-06719, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired BioMarin securities between February 28, 2020 and August 18, 2020, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased BioMarin securities during the class period, you have until November 24, 2020, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
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 adeno-associated virus ("AAV") gene therapy, which is in Phase 3 clinical development for the treatment of patients with severe hemophilia A.
Based on BioMarin's Phase 1/2 study results, the investing and medical community viewed valoctocogene roxaparvovec as a likely candidate for becoming the first gene therapy approved by the U.S. Food and Drug Administration ("FDA") for hemophilia in the U.S.
In May 2019, BioMarin announced the interim results from its Phase 3 study of valoctocogene roxaparvovec for adults suffering from severe hemophilia A. The results, although showing the treatment's effectiveness, disappointed the market because they indicated a reduction in durability of effectiveness from the results shown in the Phase 1/2 results. That is, under the Phase 3 results, it was not clear whether valoctocogene roxaparvovec's effectiveness would last as long as indicated in the Phase 1/2 study, and thus, whether valoctocogene roxaparvovec would be a single treatment, or one requiring more than one treatment over the life of a patient. These concerns echoed those that first arose in 2018, after the Company reported a disappointing two-year update from the Phase 1/2 study, which showed factor VIII levels waning over time.
Apparently dismissing these concerns, in December 2019, BioMarin submitted a Biologics License Application ("BLA") to the FDA for valoctocogene roxaparvovec for adults with hemophilia A based on the interim analysis of the ongoing Phase 3 study of valoctocogene roxaparvovec, as well as three-year data from the Company's Phase 1/2 study of valoctocogene roxaparvovec. BioMarin also announced that the European Medicines Agency ("EMA") validated the Company's Marketing Authorization Application ("MAA") for valoctocogene roxaparvovec for adults with severe hemophilia A, with the MAA review to commence in January 2020 under accelerated assessment.
The complaint 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.
On August 19, 2020, BioMarin announced receipt of a Complete Response Letter ("CRL") from the FDA to the Company'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 the 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 Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980
SOURCE Pomerantz LLP