Minerva Neurosciences Inc. (NASDAQ: NERV) stock popped after the company announced results of its 40-week open-label extension (OLE) third phase trial of roluperidone in treating negative symptoms of schizophrenia. The company conducted the OLE trial after a 12-week double-blind, placebo-controlled part of the trial. Minerva blinded patients and investigators during the trial to receive the roluperidone dose.
Results showed continuous negative symptoms improvement measured by the Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS). The company observed the improvement over a year in patients receiving 32 mg and 64 mg doses of roluperidone. Similarly, continuous Personal and Social Performance total score improvement over the year indicated enhancement of daily life functioning in patients. There were limited relapses observed, and roluperidone showed a favorable safety profile.
The results will support NDA submission after completing a bioequivalence study. Administration of roluperidone without concomitant treatment with antipsychotics showed the potential of improving negative schizophrenia symptoms. As the company gears to file an NDA, this is a stock to watch.
NERV stock is up 43% over the past week.