Why Minerva Neurosciences (NERV) Shares Are Soaring Today - Minerva Neurosciences (NASDAQ:NERV)

Minerva Neurosciences Inc 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.

Minerva Seeks FDA Approval For Its Schizophrenia Candidate