Soleno Therapeutics Inc. (SLNO)

Key Insights

• Soleno Therapeutics has voluntarily withdrawn its marketing authorization application (MAA) for VIOKAT prolonged-release tablets (diazoxide choline) in Europe, which was intended to treat Prader-Willi syndrome (PWS) in adults and children.
• The decision to withdraw the MAA is based on business and strategic considerations, which preserves the company's ability to re-engage with regulators at a later date if an appropriate pathway is identified.
• The withdrawal of the MAA is a setback for the company's efforts to expand the commercial availability of its PWS treatment, but leaves the door open for future regulatory submissions.