Minerva Neurosciences Shares Sink On Regulatory Setback For Schizophrenia Candidate

  • Minerva Neurosciences Inc NERV has received a refusal to file letter from the FDA regarding its marketing application for roluperidone for negative symptoms in patients with schizophrenia. 
  • The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.
  • "We are disappointed that the FDA has not accepted our NDA for roluperidone. Our goal remains to provide a new and much-needed therapeutic option to help patients and their families since there are currently no approved therapies to treat negative symptoms of schizophrenia in the United States," said Remy Luthringer, Executive Chairman and CEO of Minerva. 
  • Minerva submitted the application in August for roluperidone for negative symptoms in patients with schizophrenia for the 64 mg dose.
  • In the primary efficacy analysis, 64 mg roluperidone resulted in a statistically significant reduction of negative symptoms of schizophrenia.
  • Price Action: NERV shares are down 66.50% at $4.50 during the premarket session on the last check Monday.
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