Core Viewpoint - Soleno Therapeutics, Inc. has announced a public offering of 2,352,941 shares of common stock priced at $85.00 per share, aiming to raise approximately $200 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 2,352,941 shares, with an additional 30-day option for underwriters to purchase up to 352,941 more shares at the same price [1]. - The offering is expected to close on or about July 11, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds will primarily fund the commercialization of VYKAT XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Additional proceeds will support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3]. Group 3: Underwriters - Goldman Sachs & Co. LLC, Guggenheim Securities, TD Cowen, Cantor, and Oppenheimer & Co. are serving as joint book-running managers for the offering [2]. Group 4: Company Overview - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product aimed at treating hyperphagia in individuals aged 4 and older with Prader-Willi syndrome [6].

Core Insights - Soleno Therapeutics, Inc. announced the selection of two abstracts for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025) regarding VYKAT™ XR (diazoxide choline) extended-release tablets, aimed at treating hyperphagia in individuals with Prader-Willi syndrome [1][2] Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product [10] - VYKAT XR was approved by the U.S. FDA on March 26, 2025, and is now available for patients in the U.S. [3] Product Information - VYKAT XR is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3] - The product's safety information includes contraindications for patients with known hypersensitivity to diazoxide or thiazides [4] Presentation Details - The first presentation at ENDO 2025 will focus on the glycemic outcomes of VYKAT XR in treating hyperphagia over four years [2] - The second presentation will characterize peripheral edema in individuals with Prader-Willi syndrome during long-term administration of VYKAT XR over 4.5 years [6] Health Implications - Prader-Willi syndrome is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [2] - The treatment with VYKAT XR aims to address the life-threatening aspects of hyperphagia and improve the quality of life for affected individuals [2]

Core Insights - Soleno Therapeutics presented new data on VYKAT XR (diazoxide choline) extended-release tablets at the 2025 International Prader-Willi Syndrome Conference, highlighting its potential benefits for individuals with Prader-Willi Syndrome (PWS) [1][2] Group 1: Efficacy of VYKAT XR - VYKAT XR significantly reduces hyperphagia symptoms in PWS patients managed with strict food controls, showing statistically significant reductions in HQ-CT Total scores (p ≤ 0.0001) [5] - Participants in highly food-restricted environments benefited from VYKAT XR treatment similarly to those in less restricted environments, indicating broad applicability of the treatment [5] Group 2: Safety and Efficacy in Co-Morbid Conditions - 60% of study participants had evidence of pre-diabetes or diabetes (PD/DM) at baseline, with efficacy outcomes at Week 156 showing similar results for both PD/DM and normoglycemic groups (p<0.0001) [7] - Although a higher proportion of hyperglycemia-related adverse events were reported in the PD/DM group (42.7% vs 24.0%), these events were generally manageable, and treatment discontinuation rates were low (4.0% in PD/DM vs 6.0% in normoglycemic) [8][9] Group 3: Background on Prader-Willi Syndrome - Prader-Willi Syndrome is a rare genetic neurodevelopmental disorder affecting approximately 1 in every 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [10][11] - Hyperphagia in PWS can result in significant mortality and long-term co-morbidities such as diabetes, obesity, and cardiovascular disease [12] Group 4: Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in adults and pediatric patients aged 4 years and older with PWS [13][18]

Core Insights - Soleno Therapeutics, Inc. announced poster presentations for its VYKAT XR clinical development program at the Pediatric Endocrine Society Meeting 2025, focusing on hyperphagia treatment in Prader-Willi syndrome (PWS) [1][2] Group 1: Company Overview - Soleno Therapeutics is a biopharmaceutical company dedicated to developing novel therapeutics for rare diseases [10] - The company's first commercial product, VYKAT XR, is a once-daily oral treatment for hyperphagia in individuals aged 4 years and older with PWS [10] Group 2: Product Information - VYKAT XR (diazoxide choline) was approved by the U.S. FDA on March 26, 2025, and is now available for U.S. patients [4] - The product is indicated for treating hyperphagia associated with PWS [4] Group 3: Clinical Research - Presentations at PES 2025 include studies on long-term administration of VYKAT XR and its effects on lean body mass and behavioral symptoms in PWS [2][3] - The studies highlight significant improvements in hyperphagia and behavioral symptoms upon resuming treatment after a randomized withdrawal period [2]

Core Viewpoint - Soleno Therapeutics, Inc. will report its first quarter 2025 financial results and operational highlights on May 7, 2025, followed by a conference call to discuss the results and business operations [1]. Group 1: Financial and Operational Updates - The financial results and operational highlights will be announced after the close of U.S. financial markets on May 7, 2025 [1]. - A conference call and webcast will take place at 4:30 PM Eastern Time on the same day to discuss the results [1][2]. Group 2: Product Information - Soleno's primary product, VYKAT XR, is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3][9]. - VYKAT XR is a once-daily oral treatment, previously known as DCCR [9]. Group 3: Safety Information - VYKAT XR has contraindications for patients with known hypersensitivity to diazoxide or thiazides [4]. - Warnings include the risk of hyperglycemia and fluid overload, necessitating regular monitoring of fasting plasma glucose and signs of edema [5][6]. - Common adverse reactions reported include hypertrichosis, edema, hyperglycemia, and rash [7].