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

• Soleno Therapeutics Inc (NASDAQ: 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.

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