id: 694, Created by Stan Vick, Scout
BioMarin Pharmaceutical Inc. (BMRN) $39M Shareholder Settlement
How it works?
- Company agreed to pay compensation to its investors, to avoid further litigation
- We help you to prepare documents and file for compensation
03 Mar 2020Class period Start
18 Aug 2020Class period End
30 Oct 2023Claim deadline
BioMarin Pharmaceutical Inc. (BMRN) agreed to settle $39 million with investors.
On December 23, 2019, BioMarin Pharmaceutical Inc. submitted a Biologics License Application to the FDA for its investigational AAV gene therapy.
BioMarin assured investors that the FDA approval process was “going quite well,” that the FDA had been “quite collaborative” and in a “mesh” with Defendants, and that the drug would “launch in the second half of 2020".
Meanwhile, the company allegedly knew of the FDA’s concerns that the initial Phase 3 trial data showed potential issues with the long-term effectiveness of the drug due to a decline in Factor VIII levels in patients over time; and that company had no dialogue whatsoever with the FDA from mid-April 2020 to June 2020, at which point Defendants learned that a facility inspection—required for FDA approval—would not occur prior to August 21, 2020.
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 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, BioMarin’s stock price dropped from from $118.16 to $76.72.
Failure to Disclose,
Payout per Share
25 September 2020
Bernstein Litowitz Berger & Grossmann LLP (New York, NY)
Jean-Jacques Bienaimé, Henry J. Fuchs
Hon. William H. Orrick
A.B. Data Ltd
Court hearing date
08 November 2023
18 October 2023
18 October 2023
Trades matching type
+$39,000,000Total Settlement Amount