FDA hands Minerva Neurosciences refusal to file letter for its roluperidone NDA for schizophrenia

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…

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