BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

Ticker: BMRN

Class Period Start: 01/13/2020

Class Period End: 09/03/2021

Registration Deadline: 12/21/2021

BioMarin Pharmaceutical Inc. (“BioMarin” or the “Company”) is a biotechnology company that develops a variety of pharmaceuticals, including products used to treat genetic disorders and autoimmune diseases.

On November 7, 2018, BioMarin shared pre-clinical data of their BMN 307, an AAV5 mediated gene therapy, which demonstrated lifetime blood phenylalanine (“Phe”) corrections in mouse models, and announced that the Company was planning to file an investigational new drug application (“IND”) for BMN 307 with the United States Food and Drug Administration (“FDA”) in the second half of 2019. On January 13, 2020, the Company announced that the FDA granted IND status for BMN 307 for the treatment of phenylketonuria (“PKU”). On September 24, 2020, the Company announced that it had dosed the first human participant in the global Phearless Phase 1/2 study of BMN 307.

On September 5, 2021, the Defendant 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, BioMarin’s stock price fell $7.14 per share, or 8.4%, to close at $77.81 per share on September 7, 2021, the next trading day, on unusually heavy trading volume.

A securities class action has been filed against BioMarin on behalf of shareholders that purchased BioMarin shares between January 13, 2020 through September 3, 2021.  This case has been filed in the U.S. District Court for the Northern District of California.

According to the complaint, the Defendant was materially false and misleading and omitted to state: (i) BMN 307 was less safe than BioMarin had led investors to believe; (ii) BMN 307’s safety profile made it likely that the FDA would place a clinical hold on the Phearless Phase 1/2 study; (iii) accordingly, the Company had overstated BMN 307’s clinical and commercial prospects; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

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