NERV - Minerva falls 65% as FDA declines to accept marketing application for schizophrenia drug

Updated to add the share move after the trading halt.

• Minerva Neurosciences ( NASDAQ: NERV ), a biotech focused on central nervous system diseases, announced Monday that the FDA issued a "refusal to file" letter regarding its marketing application for roluperidone, a treatment targeted at schizophrenia patients. After a brief trading halt, NERV shares dropped ~65% in reaction to the news.
• Without detailing reasons for the refusal, NERV said that the FDA had notified the company could request a Type A meeting to discuss the contents of the letter.
• Schizophrenia is a mental illness affecting an estimated 20M people globally.
• "We are disappointed that the FDA has not accepted our NDA for roluperidone," Chief Executive Remy Luthringer remarked, adding, "the company intends to request a Type A meeting and looks forward to continued discussions with the FDA."
• Read: In August, NERV shares gained after the company announced the filing of the marketing application.

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