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Minerva setback doesn’t preclude big year for schizophrenia

ARTICLE | Regulation

With Karuna’s PDUFA date and several readouts on the way, 2024 is still looking like an important year for progress in treating the disease

By Selina Koch, Executive Editor

February 28, 2024 2:31 AM UTC

The first major schizophrenia milestone of the year was a denial from FDA, but 2024 is still likely to be a banner year for progress in treating the disease. A PDUFA date in September for a new therapeutic mechanism is widely expected to lead to approval, and several clinical readouts will provide insight into the viability of other compounds.

FDA’s complete response letter to Minerva Neurosciences Inc. (NASDAQ:NERV) for roluperidone was not wholly unexpected, given the agency’s initial refusal to file the application and the issues with the dataset it raised at the time…