Soleno Shares Surge On Regulatory Update For Its Prader-Willi Syndrome Hopeful

Soleno Therapeutics Inc SLNO provided an update following recent communications with the FDA regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for Prader-Willi syndrome (PWS).
The FDA acknowledged that data from a proposed randomized withdrawal phase of Study C602 would have the potential to address its concerns regarding the adequacy of the overall efficacy data supportive of a marketing application submission for DCCR.
Earlier this year, Soleno submitted a proposal to add a randomized withdrawal period to Study C602 to obtain additional controlled data requested by the FDA to support the application.
This randomized withdrawal phase would consist only of participants currently enrolled in Study C602 and not include any new patients.
The company continues to work collaboratively with the FDA to finalize specific details of the study design. It plans to initiate the randomized withdrawal period this quarter, with top-line data expected in Q1 of 2023.
Price Action: SLNO shares are up 10.30% at $0.21 during the market session on the last check Wednesday.