It is alleged in the complaint that Minerva made misleading and false statements to the market. After its “end-of-Phase 2” meeting, Minerva failed to inform investors of the FDA’s true feedback. Minerva’s Phase 2b study failed to use the commercial formulation of roluperidone and was conducted exclusively outside of the United States. Due to failing to meet its primary and key secondary endpointsMinerva’s Phase 3 study was rendered incapable of proving the drug’s effectiveness. The combination of the Phase 2b and Phase 3 trials would be “highly unlikely” to support an NDA submitted to the FDA. Throughout the class period, Minerva’s public statements were materially misleading and false, based on these facts. Investors suffered damages when the market learned the truth about Minerva.
Minerva Neurosciences, Inc.
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