NERV - Minerva slumps ~30% as FDA refusal on schizophrenia drug intact after panel meeting

• Minerva Neurosciences ( NASDAQ: NERV ) said that following a Type A meeting held on Nov. 30, the U.S. Food and Drug Administration (FDA) confirmed that the agency's refusal to review the company's application for roluperidone to treat negative symptoms in patients with schizophrenia remains in effect.
• In October, the FDA had issued a 'refusal to file' letter regarding the company's new drug application for roluperidone.
• "We are very disappointed to announce that the FDA has confirmed that it will not file our NDA for roluperidone for the treatment of negative symptoms of schizophrenia," said Minerva Executive Chairman and CEO Remy Luthringer. "We will continue to work with the FDA regarding their feedback and assess the next steps for roluperidone."
• Schizophrenia is a mental disorder. Negative symptoms can cause people with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure, according to the company.
• NERV -28.94% to $1.67 premarket Dec. 28

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