Soleno Therapeutics Inc.
Soleno Therapeutics Submits NDA for DCCR to Treat Prader-Willi Syndrome
Summary
On June 28, 2024, Soleno Therapeutics, Inc. announced the submission of a New Drug Application (NDA) to the U.S. FDA for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi Syndrome (PWS), a rare disorder characterized by hyperphagia. This submission is a significant milestone for the company as it seeks approval for a new therapeutic option for individuals with PWS. The FDA has 60 days to determine whether the NDA will be accepted for review, with Soleno requesting Priority Review which could expedite the review period to six months.
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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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