According to the Complaint, BioMarin Pharmaceutical Inc. 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 AAV gene therapy, which is in Phase 3 clinical development for the treatment of patients with severe hemophilia A.

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, the Complaint alleges 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 December 22, 2020, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on February 22, 2021. Defendants filed a Motion to Dismiss the amended Complaint on April 22. On January 6, 2022, the Court issued an Order denying Defendants' Motion to Dismiss.

The parties entered into a Stipulation and Agreement of Settlement on April 24, 2023. The Court granted preliminary approval of the Settlement on June 8. On November 14, the Court granted final approval of the Settlement, including an award of Attorneys’ Fees and Expenses, and entered Final Judgment.