Following a major regulatory approval, Soleno Therapeutics, Inc. (NASDAQ: SLNO) stock has seen a sharp increase in value. SLNO shares were trading at $67.40 as of the recent pre-market check, representing a remarkable 37.64% rise. Following the U.S. Food and Drug Administration’s (FDA) approval of the company’s most recent medication for Prader-Willi syndrome (PWS), the stock has been rising.
VYKAT XR is approved by the FDA
Soleno Therapeutics’ VYKAT XR (diazoxide choline) extended-release tablets were officially approved by the FDA. Previously known as DCCR, this newly approved medication is designed to treat hyperphagia, an insatiable hunger disorder, in PWS children aged four and above. By April 2025, Soleno expects VYKAT XR to be commercially accessible in the US, providing a much-needed treatment alternative for individuals with the disease.
A Revolution in the PWS Community
For PWS patients and their families, the approval of VYKAT XR is a revolutionary development. The quality of life for both patients and caregivers has been greatly impacted by hyperphagia, which is thought to be the most incapacitating feature of the disease and has historically needed ongoing supervision and food restriction. The introduction of VYKAT XR provides new hope for managing this critical symptom, alleviating some of the burdens faced by families who have long struggled with the condition.
Scientific Rigor and Safety Profile
The FDA’s decision was supported by extensive clinical research and well-controlled studies demonstrating the efficacy and safety of VYKAT XR. Data from the clinical program indicated that patients who transitioned to a placebo experienced a statistically significant worsening of hyperphagia compared to those who continued with VYKAT XR. On average, participants had been on the medication for 3.3 years prior to the randomized withdrawal phase.
VYKAT XR has demonstrated a well-established safety profile based on more than four years of safety data from several clinical investigations. Hypertrichosis, edema, hyperglycemia, and rash were the most often reported adverse effects, occurring in at least 10% of patients and at a rate 2% higher than placebo. These results support the medication’s ability to offer PWS patients significant comfort while keeping a tolerable safety level.