Soleno Therapeutics Inc.
Soleno Therapeutics Withdraws MAA for VIOKAT in Europe
Summary
On April 7, 2026, Soleno Therapeutics, Inc. announced the voluntary withdrawal of its marketing authorization application (MAA) for VIOKAT prolonged-release tablets, intended for the treatment of hyperphagia in adults and children with Prader-Willi syndrome. The decision, based on business and strategic considerations, was made while the application was under review by the European Medicines Agency, with a decision expected in mid-2026. This withdrawal preserves the company's option to re-engage with regulators in the future should a viable pathway emerge.
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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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