Minerva Neurosciences files NDA for schizophrenia candidate roluperidone

Shares of Clinical stage US biotech Minerva Neurosciences (Nasdaq: NERV) were up more than 5% at $4.35 pre-market, after it said it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.

The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.

“We believe that roluperidone may represent a new therapeutic option to treat patients with negative symptoms of schizophrenia for which there are currently no approved therapies in the United States. While positive symptoms of schizophrenia are generally well managed with antipsychotics, negative symptoms are often the main burden of illness and can impact the patients’ quality of life as a result of disabilities caused by impaired vocational and social skills,” said Remy Luthringer, executive chairman and chief executive.