NERV - Minerva says FDA declined to accept marketing application for schizophrenia drug
- 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.
- 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."
- NERV shares are currently on hold for trading.
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Read: In August, NERV shares gained after the company announced the filing of the marketing application.
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Minerva says FDA declined to accept marketing application for schizophrenia drug