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Home » Minerva shares marred by FDA feedback on schizophrenia program
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Minerva shares marred by FDA feedback on schizophrenia program

Dec. 1, 2020
By Michael Fitzhugh
Investors in Minerva Neurosciences Inc. on Dec. 1 gave a chilly reception to reported FDA feedback on the company's experimental treatment for the negative symptoms in schizophrenia, roluperidone. Though the drug failed to deliver statistically significant differences vs. placebo in a phase III study this year, CEO Remy Luthringer outlined a potential path to NDA filing for the candidate using a modified intent-to-treat analysis of the trial and evidence from other ongoing evaluations.
BioWorld Regulatory Neurology/psychiatric FDA

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