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. The complaint alleges that, 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. 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, 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.
The alleged class includes : All persons and entities other than Defendants that purchased or otherwise acquired BioMarin securities between January 13, 2020 and September 3, 2021, both dates inclusive.
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