Soleno Therapeutics Inc (NASDAQ: SLNO) drops in premarket trading after the FDA said that it would require an additional controlled clinical trial for DCCR (diazoxide choline) in Prader-Willi Syndrome (PWS).

• The agency said that this additional study would help support the DCCR marketing application.
• Regarding the potential adequacy of DCCR data for marketing application, the company submitted additional analyses to the FDA from Phase 3 trial, DESTINY PWS (C601), in November last year.
• These data analyses showed statistically significant changes for DCCR compared to placebo in the primary and key secondary endpoints.
• The company says that it is currently evaluating the appropriate next steps for our DCCR program.
• PWS is characterized by a constant sense of hunger (hyperphagia), which leads to severe obesity resulting in physical, mental, and behavioral problems.
• Price Action: SLNO shares tanked 37.2% at $1.69 in premarket trading on the last check Monday.