Soleno Therapeutics Inc.
Soleno Therapeutics Receives Breakthrough Therapy Designation for DCCR in PWS
Summary
On April 29, 2024, Soleno Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to diazoxide choline extended-release tablets (DCCR) for the treatment of hyperphagia in adults and children with Prader-Willi Syndrome (PWS). This is the first drug to receive such a designation for PWS, indicating the FDA's recognition of PWS as a serious condition and DCCR's potential to offer substantial improvement over existing therapies. Soleno plans to submit a New Drug Application (NDA) for DCCR in mid-2024.
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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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