A class action alleging BioMarin Pharmaceutical Inc. misled investors has survived a motion to dismiss. 

A Federal Court has held that plaintiffs have adequately plead that BioMarin Pharmaceutical Inc. and several of its executives misled investors about the progress of a new hemophilia therapy it was developing. As alleged, the defendants intentionally misrepresented their interactions with the FDA about the drug’s approval process. while BioMarin represented that it was working “closely” and “collaboratively” with the FDA to achieve accelerated approval when, in reality, it allegedly had “no dialogue” with the FDA for the period in question. BioMarin allegedly misled investors by failing to disclose warning signs from the FDA—including cancelling an important inspection of BioMarin’s manufacturing facility—that approval of its therapy would be delayed or denied while claiming to still be “on track.” When the FDA ultimately denied accelerated approval of the therapy, BioMarin’s share price dropped substantially and market participants and analysts were “shocked” due to the defendants’ previous statements.