Roth Capital Partners initiated coverage of Soleno Therapeutics (NASDAQ:SLNO) with a “buy” rating and $14 price target. The stock closed at $2.32 on June 21.
Soleno’s focus is on Prader-Wili Syndrome (PWS), a rare disease with hyperphagia, or uncontrolled eating leading to obesity, which lacks treatment options. Soleno’s lead asset, Diazoxide Choline Controlled-Release (DCCR) is a patent-protected salt of diazoxide.
“In our eyes, DCCR’s direct activity on appetite regulatory pathways makes mechanistic sense in treating the hyperphagia in PWS,” writes analyst Yasmeen Rahimi.
She said DDCR’s efficacy in PWS has been demonstrated in Phase 2 data showing reductions in hyperphagia, aggression, and body fat content.
In May 2018, Soleno began a two-part Phase 3 trial with 105 PWS patients with moderate-to-severe hyperphagia, with top-line results expected in the first half of 2019.
The primary endpoint is a change from baseline in hyperphagia measured by the Hyperphagia Questionnaire, a nine-item caregiver-reported measure of food-seeking behaviors that has been rigorously validated with close interactions with the FDA, Ms. Rahimi said.
