By Chris Wack


Minerva Neurosciences Inc. shares were up 47% to $4.57 after the company said it submitted a New Drug Application to the U.S. Food and Drug Administration for roluperidone for the treatment of negative symptoms in patients with schizophrenia.

The biopharmaceutical company said the roluperidone clinical development program looks to provide effective treatment for negative symptoms of schizophrenia.

Minerva said it has been talking with the FDA following its Type C meeting in March.

The NDA submission is supported by results from two late-stage studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia. Both studies provide long-term exposure data regarding the safety and tolerability of roluperidone, and efficacy based on blinded doses of roluperidone.

Minerva is seeking approval for the 64 mg dose of roluperidone.

The company believes that the additional data and analyses shared with the FDA further demonstrate that roluperidone satisfies the criteria for FDA approval and can address the unmet medical need in patients with schizophrenia whose positive symptoms have been stable for several months and moderate to severe negative symptoms persist.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

08-22-22 1252ET