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Investigation of BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc. (BMRN) Misled the Investing Public Regarding the Safety of its Product Candidate BMN 307

A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) securities between January 13, 2020 and September 3, 2021, for violations of the Securities Exchange Act of 1934.  BioMarin develops and commercializes therapies for people with serious and life-threatening rare diseases and medical conditions.  One of its product candidates is BMN 307, an AAV5 mediated gene therapy, which is in a phase 1/2 clinical trial to normalize blood phenylalanine (“Phe”) concentration levels in patients with phenylketonuria (“PKU”).  The Company’s Phearless Phase 1/2 study is evaluating BMN 307 in adults with PKU. 

According to the complaint, during the relevant period, defendants overstated BMN 307’s clinical and commercial prospects.  Specifically, the defendants failed to disclose that BMN 307 was less safe than BioMarin had led investors to believe and that its safety profile made it likely that the FDA would place a clinical hold on the Phearless Phase 1/2 study.

On September 5, 2021, BioMarin issued a press release announcing “that the [FDA] placed a clinical hold on the BMN 307 Phearless Phase 1/2 study,” which “is evaluating BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy, in adults with [PKU].”  BioMarin advised investors that “[t]he FDA’s clinical hold was based on interim safety findings from a pre-clinical, non GLP pharmacology study.”  On this news, shares of BioMarin stock declined $7.14 per share, or 8.4%, to close at $77.81 per share on September 7, 2021.


If you purchased shares of BioMarin Pharmaceutical Inc. (BMRN) between January 13, 2020 and September 3, 2021, you have until December 21, 2021, to ask the court to appoint you lead plaintiff for the class.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.

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