BioMarin investors may receive additional information about the case by clicking the link "Submit Your Information" above.
According to the complaint, 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 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 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 BioMarin’s Phase 1/2 study of valoctocogene roxaparvovec.
The Class Period commences on February 28, 2020. On February 27, 2020, during aftermarket hours, BioMarin filed an annual report on a Form 10-K with the SEC, reporting its financial and operating results for the quarter and year ended December 31, 2019. The Form 10-K touted regulatory review of valoctocogene roxaparvovec for the treatment of severe hemophilia A, stating, in relevant part, that “[o]n February 20, 2020, [Defendants] announced that the [FDA] accepted for priority review [the BLA] for valoctocogene roxaparvovec for the treatment of adults with severe hemophilia A”; that “[t]he submissions are based on [BioMarin’s] Phase 3 interim analysis and the three-year Phase 1/2 data of patients treated with valoctocogene roxaparvovec”; and that “[b]oth submissions represent the first time a gene therapy product for any type of hemophilia indication is under review for marketing authorization by health authorities.”
However, 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.” Following 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 alleges that, throughout the Class Period, the 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, BioMarin’s public statements were materially false and misleading at all relevant times.
If you are a member of the class described above, you may no later than November 24, 2020 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-844-887-9500 or 1-610-667-7706, or via e-mail at firstname.lastname@example.org. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.
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