Soleno Therapeutics Announces Select Preliminary Fourth Quarter and Full-Year 2025 Results

Core Insights - Soleno Therapeutics has reported strong preliminary financial results for Q4 and full-year 2025, driven by the successful launch of VYKAT XR for treating Prader-Willi syndrome (PWS) [1][5] - The company has achieved significant market penetration, with over 10% of the addressable U.S. PWS patient population having initiated treatment with VYKAT XR within nine months of its launch [1][5] - Soleno is well-funded with approximately $500 million in cash and equivalents at year-end 2025, and has achieved profitability and positive cash flow [5] Financial Performance - Preliminary unaudited net revenue for full-year 2025 from U.S. sales of VYKAT XR is expected to be between $189 million and $191 million [5] - Preliminary unaudited net revenue for Q4 2025 is anticipated to be between $90 million and $92 million [5] - The company reported a total of 1,250 new patient start forms since the launch, with 207 forms submitted in Q4 2025 [5] Market and Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in patients aged 4 years and older with PWS [4][6] - The discontinuation rate of VYKAT XR due to adverse events was approximately 12% by the end of Q4 2025 [5] - The product has been prescribed by 630 unique prescribers, including 136 new prescribers in Q4 2025 [5] Patient Demographics and Impact - The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births, highlighting the significant unmet medical need for effective treatments [3] - Hyperphagia, the defining symptom of PWS, poses serious health risks, including mortality and long-term co-morbidities such as diabetes and obesity [3]