FDA issues Complete Response Letter for roluperidone; NDA not approved

Minerva Neurosciences, Inc.

FDA cited single positive study insufficient; requires at least one additional positive well-controlled trial.
CRL also demands data on co-administration with antipsychotics and clinically meaningful change.
Safety database inadequate: too few subjects on 64 mg for 12+ months.
Minerva will request a meeting with FDA to discuss path forward; CEO expresses disappointment.
Roluperidone was targeting negative symptoms of schizophrenia, an unmet need.

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