Soleno Therapeutics Inc.
Soleno Therapeutics Announces FDA Acceptance of NDA for DCCR and Third Quarter 2024 Financial Results
Summary
Soleno Therapeutics, Inc. announced on November 6, 2024, that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) and granted it Priority Review with a PDUFA target action date of December 27, 2024. The company also reported its financial results for the third quarter ended September 30, 2024, showing a net loss of approximately $76.6 million. Additionally, Soleno updated its Board of Directors with the appointment of Dawn Carter Bir and the assumption of the Lead Independent Director role by Matthew Pauls. The company also mourned the passing of former Chairman of the Board Ernest Mario, Ph.D. Soleno's strong cash position supports its preparation for a potential U.S. market launch of DCCR, pending FDA approval.
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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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