NERV - Minerva stock rises ~15% as FDA accepts filing for schizophrenia drug

2023-05-01 08:28:28 ET

• Minerva Neurosciences ( NASDAQ: NERV ) said the U.S. Food and Drug Administration (FDA) filed the company's new drug application (NDA) for roluperidone to treat negative symptoms in patients with schizophrenia.
• The decision to file the NDA follows Minerva's request for formal dispute resolution and appeal of FDA's October 2022 decision declining to accept the NDA in the so called refuse to file letter.
• Minerva added that in in granting the appeal, the FDA agreed with the company that the issues cited in the refuse-to-file decision should be considered during agency's review of the NDA.
• "We thank the FDA for its thoughtful review and consideration of our materials submitted during the formal dispute resolution process," said Minerva's Chairman and CEO  Remy Luthringer.
• NERV +17.86% to $3.30 premarket May 1

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