NERV - Minerva soars ~10% as schizophrenia drug gets FDA review

2023-05-10 09:06:14 ET

• The U.S. Food and Drug Administration (FDA) accepted to review Minerva Neurosciences' ( NASDAQ: NERV ) application seeking approval of roluperidone to treat negative symptoms in patients with schizophrenia.
• Earlier in May, the FDA filed the company's new drug application (NDA) after Minerva's request for formal dispute resolution and appeal of the agency's October 2022 decision declining to accept the NDA in a so called refuse to file letter.
• The FDA has granted a standard review and the drug regulator is expected to make a decision on the NDA by Feb. 26, 2024.
• NERV +10.29% to $7.50 premarket May 10

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