regulatory
confidence high
sentiment negative
materiality 0.75
Soleno withdraws EU marketing application for VIOKAT (PWS hyperphagia)
SOLENO THERAPEUTICS INC
- Voluntarily withdrew MAA for VIOKAT (diazoxide choline) from EMA for Prader-Willi syndrome hyperphagia.
- Decision based on business and strategic considerations; company may re-engage with regulators later.
- VIOKAT is marketed in the US as VYKAT XR for adults and children aged 4+ with PWS.
item 8.01