Soleno Shares Skyrocket 500% as New Drug Controls Hunger in Obesity-Causing Rare Disease

Soleno Therapeutics (Nasdaq: SLNO) shares skyrocketed more than 500% after the company announced positive topline results for a long term treatment study evaluating DCCR (Diazoxide Choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS).

PWS is characterized by hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, food preoccupation, extreme drive to food seek and consume food that severely diminish the quality of life for patients with PWS and their families.

Highlights

Anish Bhatnagar, M.D., Chief Executive Officer of Soleno said, “These results will support our planned submission of a New Drug Application to the FDA mid-year of next year. We remain committed to the goal of delivering DCCR, if approved, as an effective and safe therapy to individuals with PWS as expeditiously as possible.”

Soleno’s multi-center, randomized, double-blind, placebo-controlled randomized withdrawal period enrolled 77 patients previously enrolled in Study C602 who had been on open-label treatment with DCCR for between two and four years.

The study demonstrated that hyperphagia-related behaviors markedly worsened in the placebo group compared to DCCR, and DCCR was  well-tolerated with no new or unexpected safety signals, or serious adverse events.

DCCR has Orphan Drug designation for the treatment of PWS in the US and EU and Fast Track designation from the FDA.

About Soleno Therapeutics

Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of PWS, recently completed its Phase 3 development program to support a planned NDA submission. For more information, please visit www.soleno.life.