According to the lawsuit, defendants provided investors with material information concerning Ultragenyx’s expected results for its Phase III Orbit and Cosmic Studies, which tested setrusumab (UX 143) in patients with Osteogenesis Imperfecta (“OI”). Defendants’ statements included, among other things, confidence in setrusumab’s ability to ultimately trigger a decrease in the OI patients’ annualized fracture rate, alongside confidence in the study designs to demonstrate such ability and reduce testing variability that could interfere with such a result.
The lawsuit claims that defendants provided these overwhelmingly positive statements to investors while simultaneously disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of setrusumab’s potential, as well as the true risk inherent in the study protocols put forth; notably, that while setrusumab does increase material bone density, this increase does not correlate to a decrease in annualized fracture rates or otherwise, that the Phase III Orbit and Cosmic studies were much less likely to be able to demonstrate such a link than management claimed. The lawsuit claims that such statements absent these material facts caused Ultragenyx shareholders to purchase Ultragenyx securities at artificially inflated prices.
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