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BMRN.US

BioMarin Pharmaceutical Inc. (BMRN) $39M Shareholder Settlement

Claim deadline for this case already passed by, but we can still try and file for compensation for you
N.D. California
Court
3:20-CV-06719
Case number
03 Mar 2020
Class period Start
18 Aug 2020
Class period End
30 Oct 2023
Claim 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.
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Payout per Share
1.41
Filing date
25 September 2020
Plaintiffs
Arbejdsmarkedets Tillægspension
Attorneys
Bernstein Litowitz Berger & Grossmann LLP (New York, NY)
Defendants
Jean-Jacques Bienaimé, Henry J. Fuchs
Judge
Hon. William H. Orrick
Administrator
A.B. Data Ltd
Court hearing date
08 November 2023
Exclusion deadline
18 October 2023
Objection deadline
18 October 2023
Trades matching type
FIFO
+$39,000,000
Total Settlement Amount
Created by Stan Vick, Scout

Biomarin Pharmaceutical Inc

BioMarin Pharmaceutical Inc. develops and commercializes therapies for people with serious and life-threatening rare diseases and medical conditions. Its commercial products include Vimizim, an enz...

    Ticker
    BMRN.US
    ISIN
    US09061G1013
    CIK
    1048477
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    770 Lindaro Street, San Rafael, CA, United States, 94901