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Soleno Therapeutics Inc.
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Soleno Therapeutics Inc.

Soleno Therapeutics Announces FDA Approval and Q1 2025 Financial Results

| 8-K |Healthcare

Summary

Soleno Therapeutics, Inc. announced on May 7, 2025, the FDA approval of VYKAT XR for treating hyperphagia in Prader-Willi syndrome patients aged four and older. The company reported Q1 2025 financial results, including a net loss of approximately $43.8 million. The approval led to high interest, with 268 patient start forms and 131 unique prescribers within a few weeks. Soleno also reported $290.0 million in cash, cash equivalents, and marketable securities as of March 31, 2025.

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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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