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Soleno Shares Are Trading Lower After FDA Demands Additional Study For DCCR Program In Prader-Willi Syndrome


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.

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Posted-In: Prader-Willi SyndromeBiotech News Penny Stocks Health Care FDA General

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