REDWOOD CITY, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the appointment of Jennifer Fulk as Chief Financial Officer, succeeding James Mackaness, who announced that he will be retiring from the Company by the end of the first quarter. Mr. Mackaness will serve as a consultant to Soleno through the end of the year to ensure a smooth transition. Mrs. Fu ...

Core Insights - Soleno Therapeutics, Inc. announced the publication of a study in the Journal of Clinical Endocrinology and Metabolism, detailing the efficacy and safety of VYKAT™ XR for treating hyperphagia in Prader-Willi syndrome (PWS) [1][2][3] Study Details - The study was a 16-week randomized withdrawal study involving 77 participants aged 4 years and older, previously treated in Phase 3 studies [2][6] - Participants were randomized 1:1 to receive either VYKAT XR (n=38) or placebo (n=39), with the primary endpoint being the change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score from baseline to week 16 [6] Efficacy and Safety - The study confirmed the safety and efficacy of VYKAT XR, showing significant worsening of hyperphagia in the placebo group compared to those on VYKAT XR (P=0.0022) [6] - Secondary endpoints, including Clinical Global Impression of Severity (CGI-S) and Improvement (CGI-I), favored VYKAT XR, although they did not reach statistical significance [6] - Adverse events were similar across both treatment arms, with no serious adverse events reported in the VYKAT XR group [6] Background on Prader-Willi Syndrome - PWS is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [5][7] Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for treating hyperphagia in individuals with PWS aged 4 years and older [8][13]

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].

Core Viewpoint - Soleno Therapeutics, Inc. experienced a significant drop in share price by $18.78 (-28%) following disappointing news regarding its drug VYKAT™ XR, which is intended to treat hyperphagia associated with Prader-Willi syndrome [1][2]. Company Performance - The company had previously assured investors of a successful launch of VYKAT™ XR after receiving FDA approval, stating that the launch "has been going really well" and "definitely exceeded our expectations" [2]. - However, during the Q3 2025 earnings call, Soleno disclosed a disruption in the launch trajectory, citing a lower number of start forms and increased discontinuations due to non-serious adverse events [2]. Market Reaction - Following the negative news, Soleno's share price fell nearly 40% from August 14, 2025, to November 5, 2025 [4]. - The market reaction was influenced by concerns raised by short seller Scorpion Capital, which highlighted potential risks associated with VYKAT™ XR, including reports of children hospitalized for heart failure after using the drug [3][4]. Investigations and Allegations - Hagens Berman, a national shareholders rights firm, is investigating whether Soleno misled investors regarding the commercial prospects of VYKAT™ XR [5]. - Scorpion Capital characterized Soleno as a "one-trick pony" with no other significant assets or pipeline, raising doubts about the company's future if VYKAT™ XR fails [3][4]. - Allegations were made regarding the integrity of clinical trial data and the influence of a controversial physician involved in key trials, suggesting potential irregularities in the company's disclosures [4].

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].