Tsantes v. BioMarin Pharmaceutical Inc., et al

Court: United States District Court for the Northern District of California
Case Number: 3:20-cv-06719
Class Period: 02/28/2020 - 08/18/2020
Case Leaders: Jonathan D. Uslaner, Jeroen van Kwawegen, Avi Josefson
Case Team: Thomas Sperber

On September 25, 2020, a class action lawsuit was filed in the U.S. District Court for the Northern District of California alleging violations of the federal securities laws against BioMarin Pharmaceutical Inc. (“BioMarin” or the “Company”) and certain of the Company’s senior executives (collectively, “Defendants”).  The lawsuit was brought on behalf of investors in BioMarin that purchased BioMarin stock between February 28, 2020 and August 18, 2020, inclusive (the “Class Period”).  BLB&G currently is undertaking an investigation into the misconduct alleged in the complaint.

BioMarin’s Alleged Fraud

Throughout the Class Period, Defendants made materially false and misleading statements regarding the durability and efficacy data for BioMarin’s gene therapy treatment for hemophilia A, Valrox (valoctocogene roxaparvovec), and the likelihood that the Company’s December 23, 2019 Biologics License Application (BLA) would be approved by the FDA by August 21, 2020 on the basis of preliminary Phase 3 trial data.  Despite that initial Phase 3 trial data submitted to the FDA showed potential issues with the long-term effectiveness of the drug due to a decline in Factor VIII levels in patients over time, BioMarin assured investors that it was “pretty impressive data” that showed “phenomenal hemostatic efficacy,” and that investors should not be concerned that it would negatively impact the FDA approval process, which was “going quite well” with a “high likelihood of approval” and would allow the drug to “launch[] in the second half of” 2020.

The truth emerged on August 19, 2020, when BioMarin announced that the Company had received a Complete Response Letter from the FDA, which included the FDA’s concerns about the initial Phase 3 data’s indication of a declining durability of effect.  BioMarin disclosed that the FDA declined to approve the BLA and would require that BioMarin complete its Phase 3 trial and submit two-year follow-up safety and efficacy data on all participants before any possible approval.  Accordingly, FDA approval of BioMarin’s BLA for Valrox cannot happen until at least 2022.  In response to these disclosures, BioMarin’s stock price dropped $41.82 per share, or 35.28%, to close at $76.72 per share on August 19, 2020.

On November 24, 2020, BLB&G client ATP moved for appointment as lead plaintiff.  On December 22, 2020, the Court appointed ATP lead plaintiff and BLB&G lead counsel.  On February 22, 2021, lead plaintiff filed the amended complaint.

Defendants’ answer, motion to dismiss, or other response to the amended complaint is due on or before April 22, 2021.