- Minerva Neurosciences Inc NERVE has received one Refusal to submit a letter from the FDA regarding their Marketing Authorization Application for Roluperidone for Adverse Symptoms in Patients with Schizophrenia.
- The FDA has indicated that the company may request a Type A meeting to discuss the content of the denial letter.
- “We are disappointed that the FDA did not accept our NDA for roluperidone. Our goal remains to provide a new and much-needed therapeutic option to help patients and their families as there are currently no approved therapies to treat negative symptoms of schizophrenia in the United States,” said Remy Luthringer, Executive Chairman and CEO by 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 promotion: NERV shares are down 66.50% to $4.50 during the premarket session last check Monday.
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