- Minerva Neurosciences ( NASDAQ: NERV ) filed an application to the U.S. Food and Drug Administration (FDA) seeking approval of roluperidone to treat negative symptoms in patients with schizophrenia.
- The company's new drug application (NDA) was backed by data from two late-stage studies (MIN-101C03 and MIN-101C07) in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia.
- Minerva is seeking approval for the 64-mg dose of roluperidone.
- "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 Executive Chairman and CEO Remy Luthringer.
- The company noted that there are currently no treatments approved for negative symptoms of schizophrenia in the U.S.
- NERV +7.89% to $3.35 premarket Aug. 22
For further details see:
Minerva stock rises on filing for FDA approval of schizophrenia therapy