Minerva mauled over roluperidone CRL

CNS specialist Minerva Neurosciences (Nasdaq: NERV) lost 59% of its stock market value on Tuesday.

Investors were reacting to the news that Minerva had received a Complete Response Letter (CRL) to the company’s New Drug Application (NDA) for its lead product, roluperidone, for the treatment of negative symptoms in patients with schizophrenia.

"We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback"In the CRL, the US Food and Drug Administrato  (FDA) wrote that although one study demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness.