Soleno Therapeutics Inc.
Soleno Therapeutics Receives FDA Approval for VYKAT XR to Treat Hyperphagia in Prader-Willi Syndrome
Summary
Soleno Therapeutics, Inc. announced on March 26, 2025, that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets for the treatment of hyperphagia in adults and pediatric patients four years of age and older with Prader-Willi syndrome (PWS). This marks the first approved therapy specifically targeting hyperphagia in PWS patients, offering a significant treatment option for the PWS community. Soleno expects VYKAT XR to be available in the U.S. starting in April 2025. The approval was based on comprehensive clinical trial data, demonstrating the efficacy and safety of VYKAT XR in reducing hyperphagia. Additionally, Soleno has launched Soleno One, a patient support program to assist patients in accessing the treatment.
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About Soleno Therapeutics Inc.
Soleno Therapeutics Inc. is a biopharmaceutical company dedicated to the development and commercialization of novel therapeutics for rare diseases. Its primary focus lies on the treatment of genetic disorders that have a significant medical need, such as Prader-Willi syndrome, a complex condition that affects the musculoskeletal and endocrine systems. Soleno is committed to pioneering advancements in the pharmaceutical industry by leveraging innovative approaches to drug development. The company's lead treatment candidate, rooted in addressing metabolic and neurobehavioral abnormalities, plays a critical role within its pipeline. Soleno's research and development efforts are concentrated on improving patient outcomes through therapies that target underlying disease mechanisms. Based in Redwood City, California, Soleno Therapeutics Inc. actively collaborates with scientific communities and healthcare providers to enhance its therapeutic offerings. In the financial market, Soleno Therapeutics is notably positioned as part of the healthcare and biotechnology sectors, reflecting its significance in developing treatments that can transform patient care and address unmet medical needs in niche and complex disease areas.
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