VYKAT™ XR

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INVESTOR ALERT: Investigation of Soleno Therapeutics, Inc. (SLNO) Announced by Holzer & Holzer, LLC
GlobeNewswire News Room· 2025-08-19 17:38
Core Points - Holzer & Holzer, LLC is investigating Soleno Therapeutics, Inc. for potential violations of federal securities laws following a report by Scorpion Capital that questioned the credibility of the company's phase 3 clinical trials for its drug VYKAT™ XR [1] - The report from Scorpion Capital highlighted numerous problems with the clinical trials and withdrawal studies, leading to a decline in Soleno Therapeutics' stock price [1] Company Overview - Soleno Therapeutics, Inc. is publicly traded on NASDAQ under the ticker SLNO and is focused on developing treatments, including VYKAT™ XR [1] - The company is currently facing scrutiny regarding its compliance with securities laws due to allegations of issues in its clinical trial processes [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation and has a history of representing shareholders in class action lawsuits [3] - The firm has been recognized as a top-rated securities litigation law firm for multiple years and has recovered significant amounts for investors affected by corporate misconduct [3]
Soleno Therapeutics (SLNO) Drops Amid Critical Scorpion Report -- Hagens Berman
GlobeNewswire News Room· 2025-08-19 12:21
Core Viewpoint - Soleno Therapeutics, Inc. has faced a significant decline in share price following a critical report by Scorpion Capital, which raised serious concerns about the safety and commercial viability of its drug VYKAT™ XR [1][4]. Company Overview - Soleno Therapeutics is focused on developing treatments for Prader-Willi syndrome, with its primary product being VYKAT™ XR, a once-daily oral tablet aimed at treating hyperphagia, a condition associated with the syndrome [2][4]. Investigation Details - Hagens Berman has initiated an investigation into Soleno to determine if the company misled investors regarding the safety and commercial prospects of VYKAT™ XR [2][3][6]. - The investigation will scrutinize Soleno's statements about the drug's safety and its commercial potential, particularly in light of recent adverse reports [3][6]. Critical Report Findings - Scorpion Capital's report highlighted a concerning trend of children being hospitalized for potential heart failure after using VYKAT™ XR, suggesting that the drug may face market withdrawal or a significant drop in new prescriptions [4][5]. - The report characterized Soleno as a "one-trick pony," emphasizing the lack of other meaningful assets or scientific programs, and warned of the company's potential demise if VYKAT™ XR fails, especially with its core patent expiring in 2026 [4][5]. Concerns Raised - Scorpion Capital criticized Soleno's launch metrics as misleading and pointed to a controversial physician involved in key trials, suggesting potential issues with data integrity and scientific standards [5][6]. - Allegations were made regarding irregularities in the physician's co-authored papers, which could undermine the validity of Soleno's trials and FDA submissions [5].
Soleno Therapeutics Announces Proposed $200 Million Public Offering of Common Stock
GlobeNewswire· 2025-07-10 10:01
Core Viewpoint - Soleno Therapeutics, Inc. plans to offer and sell $200 million of its common stock in an underwritten public offering, with an additional option for underwriters to purchase up to $30 million more [1][2]. Group 1: Offering Details - The public offering is subject to market conditions, and there is no assurance regarding the completion or terms of the offering [1]. - Goldman Sachs & Co. LLC and Guggenheim Securities are acting as the joint book-running managers for the offering [2]. - The shares will be offered under a registration statement previously filed with the SEC, and a preliminary prospectus will be made available [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to 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]. - Proceeds will also support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3][6].