Soleno Therapeutics, Inc.'s hopes of marketing the first ever treatment for Prader-Willi syndrome (PWS) took another hit this week when the US Food and Drug Administration told the Californian pharma that an additional Phase III study evaluating its lead compound in the disease would be needed before a regulatory filing can be made.
Soleno had already submitted additional analyses to the FDA from its Phase III trial, DESTINY PWS (C601) to support its new drug application for diazoxide-choline controlled release (DCCR) tablets
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