Minerva Neurosciences, Inc. Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company, which focused on the development and commercialization of product candidates to treat patients suffering from central nervous system (CNS) diseases. It is engaged in developing roluperidone for the treatment of negative symptoms in patients with schizophrenia and have exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson's disease. It has also co-developed seltorexant for the treatment of insomnia disorder and adjunctive treatment of the major depressive disorder (MDD). Roluperidone is a compound that blocks serotonin, sigma, and a-adrenergic receptors that are involved in the regulation of mood, cognition, sleep, and anxiety. Roluperidone has been designed to block a specific subtype of serotonin receptor called 5-HT2A. MIN-301 is a soluble recombinant form of the Neuregulin-1b1 (NRG-1b1), protein, for the treatment of Parkinson's disease and for other neurodegenerative disorders.