Soleno Therapeutics Inc. has announced the launch of VYKAT XR, the first FDA-approved treatment for hyperphagia in adults and pediatric patients aged four years and older with Prader-Willi syndrome $(PWS)$. The company highlighted a defined U.S. market opportunity of over $5 billion and a target patient population of approximately 10,000 individuals. VYKAT XR is protected by multiple layers of granted and pending patents extending into the mid-2030s, and Soleno reported achieving profitability and positive cash flow in the third quarter of 2025. Clinical trial data presented showed sustained reductions in hyperphagia, as measured by HQ-CT total scores, over multiple years in open-label and controlled studies. The company also emphasized the significant burden PWS places on patients, caregivers, and healthcare systems, including higher rates of hospital stays and increased caregiver stress. You can access the full presentation through the link below.