Core Insights - Soleno Therapeutics, Inc. experienced a significant drop in share price, falling $18.78 (-28%) following disappointing news regarding its drug VYKAT™ XR, which is intended to treat hyperphagia associated with Prader-Willi syndrome [1] Company Performance - The company had previously assured investors of a successful launch of VYKAT™ XR after receiving FDA approval, claiming it "exceeded expectations" [3] - However, during the Q3 2025 earnings call, Soleno disclosed disruptions in the launch trajectory, citing a lower number of start forms and increased discontinuations due to non-serious adverse events [3] Market Reaction - Following the negative news, Hagens Berman, a national shareholders rights firm, initiated an investigation into Soleno, focusing on the accuracy of the company's statements regarding the safety and commercial prospects of VYKAT™ XR [2][6] - The investigation was prompted by concerns raised by short seller Scorpion Capital, which highlighted reports of children hospitalized for potential heart failure after using the drug [4] Competitive Position - Scorpion Capital characterized Soleno as a "one-trick pony" with no other significant assets or pipeline, emphasizing the risk of the company's failure if VYKAT™ XR does not succeed, especially with its core patent expiring in 2026 [4] - The report also questioned the integrity of Soleno's launch metrics and raised concerns about a controversial physician involved in key trials, suggesting potential irregularities in data integrity [5] Financial Impact - Since the publication of Scorpion's report on August 14, 2025, Soleno's share price has declined nearly 40% by November 5, 2025 [5]

Core Viewpoint - Johnson Fistel, PLLP is investigating potential violations of federal securities laws by Soleno Therapeutics, Inc. and its officers regarding misleading statements and undisclosed material information to investors [1][2]. Group 1: Investigation Details - The investigation focuses on whether Soleno's communications accurately represented the commercial progress and safety profile of VYKAT™ XR after its FDA approval [2]. - Following the FDA clearance in September 2025, Soleno claimed that the product rollout was exceeding internal expectations [2]. Group 2: Earnings Call Insights - During the third-quarter earnings call on November 4, 2025, Soleno acknowledged challenges in the launch of VYKAT™ XR, including a slowdown in new treatment initiations and an increase in therapy discontinuations due to non-serious adverse events [3]. - Management indicated that external commentary earlier in the year had negatively impacted the launch trajectory [3]. Group 3: Short Seller Report - On August 15, 2025, Scorpion Capital released a report raising concerns about VYKAT™ XR, questioning its safety profile, demand sustainability, and the concentration of early prescribing activity [4]. - The report criticized Soleno's business model for being overly reliant on a single product with impending intellectual property expiration and suggested that certain clinical research needed further examination [4]. Group 4: Stock Price Volatility - Following the Scorpion report, Soleno's stock price experienced significant volatility, declining nearly 40% from August 14, 2025, to November 5, 2025 [5].

Accessibility StatementSkip Navigation Then, during Soleno's November 4, 2025 Q3 2025 earnings call, the company revealed that "we did see a disruption in our launch trajectory […] mostly in the form of a lower number of start forms and increase[d] discontinuations for non-serious adverse events." Back on August 15, 2025, short seller Scorpion Capital raised questions about Soleno's disclosures and made several observations regarding VYKATâ"¢ XR. SLNO Investors with Losses Encouraged to Contact Hagens Berma ...

Core Insights - Soleno Therapeutics has appointed Mark W. Hahn as an independent director to its Board of Directors, enhancing the board's expertise with nearly 30 years of CFO-level experience in the biopharmaceutical sector [1][2] - The addition of Mr. Hahn brings the total number of board members to seven, which is expected to support the company's ongoing commercial launch of VYKAT™ XR [1][2] Company Overview - Soleno Therapeutics is focused on developing novel therapeutics for rare diseases, with its first commercial product, VYKAT™ XR, approved by the FDA on March 26, 2025 [11] - VYKAT™ XR is indicated for treating hyperphagia in patients aged 4 years and older with Prader-Willi syndrome (PWS) [6][11] Leadership and Experience - Mark W. Hahn has a strong background in financial leadership, having served as CFO for several companies, including Verona Pharma PLC and Dova Pharmaceuticals, where he played key roles in product launches and capital raising [2][3] - His experience includes overseeing Verona Pharma's phase 3 program and its acquisition by Merck & Co., Inc. for approximately $10 billion [2] Product Information - VYKAT™ XR is designed to address hyperphagia, a severe condition associated with PWS, which can significantly impact the quality of life for affected individuals [5][6] - The product is now commercially available to U.S. patients following its FDA approval [6][11]

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]

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].

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].