Corporate Update - Soleno Therapeutics is preparing for the anticipated U.S. launch of its drug DCCR for Prader-Willi syndrome (PWS) and has strengthened its commercial organization [3][6] - The New Drug Application (NDA) for DCCR was accepted by the FDA and granted Priority Review, with a new PDUFA target action date set for March 27, 2025 [7] - The company has made strategic investments in commercial and medical affairs programs, including education and data analytics [3][6] Financial Results - For the year ended December 31, 2024, Soleno reported a net loss of approximately 4.38 per share, compared to a net loss of 2.36 per share, in 2023 [16][27] - Operating expenses for the year totaled 78.6 million and general and administrative expenses at 318.6 million in cash, cash equivalents, and marketable securities as of December 31, 2024 [9] Research and Development - Research and development expenses increased significantly, with a total of 25.2 million in 2023 [10][11] - The increase in expenses was attributed to hiring additional employees and consulting costs related to NDA submissions [11][13] - DCCR has shown promise in clinical trials for addressing hyperphagia and other symptoms associated with PWS [19] Corporate Governance - Dawn Carter Bir was appointed to Soleno's Board of Directors, bringing over 30 years of biotechnology executive leadership experience [8] - The company has also made changes in its board structure, with Matthew Pauls assuming the role of Lead Independent Director [8] Market Position - PWS is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia and other significant health challenges [17][18] - There are currently no approved therapies for the treatment of hyperphagia and other symptoms associated with PWS, highlighting the potential market opportunity for DCCR [18][19]
Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2024 Financial Results