regulatory
confidence high
sentiment negative
materiality 0.85
Minerva Neurosciences receives FDA refusal to file for roluperidone NDA in schizophrenia negative symptoms
Minerva Neurosciences, Inc.
- FDA issued Refusal to File letter for NDA of roluperidone for negative symptoms of schizophrenia.
- No approved therapies exist in US for negative symptoms of schizophrenia; company disappointed.
- Company intends to request a Type A meeting to discuss the refusal to file letter.
- Roluperidone is a clinical-stage therapy; NDA submission not accepted by FDA.