BioMarin Pharmaceutical Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California on behalf of those who acquired BioMarin Pharmaceutical Inc. (“BioMarin” or the “Company”) (NASDAQ: BMRN) securities from January 13, 2020 through September 3, 2021, inclusive (the “Class Period”). Investors have until December 21, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
BioMarin develops and commercializes therapies for people with serious and life-threatening rare diseases and medical conditions. The Company is developing, among other product candidates, 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.
On November 7, 2018, BioMarin shared pre-clinical data of BMN 307, which demonstrated lifetime 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 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, 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, the Company’s share price declined by $7.14 per share, or approximately 8.4%, from $84.95 per share to close at $77.81 per share on September 7, 2021.
The lawsuit alleges throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (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.