Genetic Disorder Focused Soleno Therapeutics' Stock Is Trading 4X Today - Here's Why?

Soleno Therapeutics Inc SLNO released top-line results from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for Prader-Willi syndrome (PWS).

PWS is a genetic disorder that causes obesity, intellectual disability, and shortness of height. It is characterized by constant craving for food.

The primary endpoint was the change from baseline in hyperphagia (extreme, insatiable hunger)-related behaviors as assessed by the hyperphagia questionnaire for clinical trials (HQ-CT).

Secondary endpoints included investigator assessments of participants' overall severity of illness and change in condition, as measured by Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) ratings, respectively.

Hyperphagia-related behaviors markedly worsened in the placebo group compared to DCCR, represented by a statistically significant, clinically meaningful difference in mean change from baseline in the HQ-CT total score of 5.0 at week 16 (p=0.0022).

Secondary endpoints of CGI-S and CGI-I showed strong trends towards worsening in the placebo group compared to DCCR over the randomized withdrawal period (p=0.08 and 0.09), respectively.

DCCR continued to be generally well-tolerated.

Price Action: SLNO shares are up 409.3% at $22.18 during the premarket session on the last check Tuesday.