- Minerva Neurosciences Inc (NASDAQ:NERV) submitted a marketing application to the FDA for roluperidone for negative symptoms in patients with schizophrenia.
- “We have been in dialogue with the FDA following our Type C meeting in March 2022, and we look forward to working with the FDA as it evaluates the NDA,” said Remy Luthringer, Executive Chairman and CEO.
- Related: Minerva Outlines Next Steps For US Application For Schizophrenia Candidate.
- The submission is supported by results from two late-stage studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia.
- Minerva is seeking approval for the 64 mg dose of roluperidone, and the results described hereafter are for the 64 mg dose only.
- Also See: Minerva Shares Surge As Schizophrenia Candidate Shows Long Term Improvement In Negative Symptoms, Functioning.
- In the primary efficacy analysis, 64 mg roluperidone resulted in a statistically significant reduction of negative symptoms of schizophrenia.
- Price Action: NERV shares are up 18.8% at $3.69 on the last check Monday.
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