The biopharma Minerva Neurosciences (Nasdaq:NERV) announced that it had received a refusal to file letter from the FDA for its New Drug Application (NDA) for roluperidone.
The NDA covered the use of the drug candidate as a treatment for the negative symptoms in schizophrenia patients. Negative schizophrenia symptoms can include social withdrawal, mood flatness and depression.
Drug candidates that get a refusal to file letter have slim chances of winning FDA approval.
Roluperidone is a 5-HT2A and sigma2 receptor antagonist.
FDA informed Burlington, Massachusetts–based Minerva Neurosciences that the company can ask for a Type A meeting to review the content of the refusal to file letter. Accordingly, the company plans to request such a meeting.
“We are disappointed that the FDA has not accepted our NDA for roluperidone,” said Remy Luthringer, CEO of Minerva Neurosciences. “Our goal remains to provide a new and much-needed therapeutic option t…