Financial Results - Soleno Therapeutics, Inc. announced preliminary financial results for Q4 and the full year ended December 31, 2025[4] - The press release detailing these results was issued on January 12, 2026[4] Company Information - The company is listed on NASDAQ under the ticker symbol SLNO[2]

Core Insights - Soleno Therapeutics has reported strong preliminary financial results for Q4 and full-year 2025, driven by the successful launch of VYKAT XR for treating Prader-Willi syndrome (PWS) [1][5] - The company has achieved significant market penetration, with over 10% of the addressable U.S. PWS patient population having initiated treatment with VYKAT XR within nine months of its launch [1][5] - Soleno is well-funded with approximately $500 million in cash and equivalents at year-end 2025, and has achieved profitability and positive cash flow [5] Financial Performance - Preliminary unaudited net revenue for full-year 2025 from U.S. sales of VYKAT XR is expected to be between $189 million and $191 million [5] - Preliminary unaudited net revenue for Q4 2025 is anticipated to be between $90 million and $92 million [5] - The company reported a total of 1,250 new patient start forms since the launch, with 207 forms submitted in Q4 2025 [5] Market and Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in patients aged 4 years and older with PWS [4][6] - The discontinuation rate of VYKAT XR due to adverse events was approximately 12% by the end of Q4 2025 [5] - The product has been prescribed by 630 unique prescribers, including 136 new prescribers in Q4 2025 [5] Patient Demographics and Impact - The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births, highlighting the significant unmet medical need for effective treatments [3] - Hyperphagia, the defining symptom of PWS, poses serious health risks, including mortality and long-term co-morbidities such as diabetes and obesity [3]

Core Viewpoint - Kirby McInerney LLP is investigating Soleno Therapeutics, Inc. for potential violations of federal securities laws or unlawful business practices related to its product Vykat XR [1] Group 1: Company Performance and Events - On August 15, 2025, Scorpion Capital published a report labeling Vykat XR as overpriced and potentially unsafe for children, leading to a decline in Soleno's share price by $5.73, or approximately 7.41%, from $77.36 to $71.64 [3] - During the quarterly earnings call on November 4, 2025, Soleno disclosed a discontinuation rate of approximately 8% for Vykat XR due to adverse effects, which contributed to a further decline in share price by $16.98, or approximately 26.59%, from $63.85 to $46.87 [4]

Group 1 - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is recognized by Wall Street analysts as one of the stocks expected to bounce back, with LifeSci Capital reiterating a Buy rating and a price target of $110 [1] - Piper Sandler has identified Soleno Therapeutics as a commercial-stage biotech company poised for transformational growth in 2026, following insights gained from discussions at a Healthcare Conference [2][3] - The company has a solid plan for drug launches and progress, which has led to improved confidence from analysts [3] Group 2 - On January 5, Soleno Therapeutics announced pivotal study results for VYKAT XR, published in the Journal of Clinical Endocrinology and Metabolism, which established the drug's efficacy and safety [4] - The study supports VYKAT XR's approval by the FDA as the first and only treatment for hyperphagia in individuals with Prader-Willi syndrome [4] - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, indicating a specialized market approach [5]

Industry Overview - The drug and biotech sector has shown recovery after a sluggish first half, supported by drug pricing agreements with the Trump administration and renewed M&A activity [1][4] - Innovation in areas such as obesity treatments, gene therapy, inflammation, and neuroscience continues to drive growth, despite challenges like pipeline setbacks and regulatory uncertainty [2][3] Market Performance - The Zacks Medical-Drugs industry has underperformed compared to the Zacks Medical sector and the S&P 500 over the past year, with a collective rise of 1.2% compared to 3.4% and 18.9% respectively [13] - The industry currently holds a Zacks Industry Rank of 90, placing it in the top 37% of 244 Zacks industries, indicating potential for outperformance [12] Valuation Metrics - The industry is trading at a trailing 12-month price-to-sales (P/S) ratio of 2.25, lower than the S&P 500's 6.03 and the Zacks Medical sector's 2.61 [16] Key Companies and Their Prospects - **Ironwood Pharmaceuticals**: Developing apraglutide for short bowel syndrome, with a significant rise in stock price by 178.9% in the past three months and a consensus estimate for 2026 earnings increasing from $0.40 to $0.47 [20][22] - **Rigel Pharmaceuticals**: Sales of Tavalisse rose by approximately 54% in the first nine months of 2025, with a stock increase of 46.7% and a consensus estimate for 2026 earnings rising from $3.70 to $4.30 [24][27] - **Soleno Therapeutics**: Launched Vykat XR for Prader-Willi syndrome, generating around $99 million in sales since April, with a stock decline of 25.7% but a rising consensus estimate for 2026 earnings from $3.10 to $3.59 [29][30] - **Marker Therapeutics**: Focused on next-generation T cell therapies, with a stock increase of 75.5% and a narrowing consensus estimate for 2026 loss per share from $4.92 to $1.86 [33][34] - **Nektar Therapeutics**: Developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with a stock decline of 26.0% but a narrowing consensus estimate for 2026 loss per share from $12.17 to $10.81 [36][38]

Group 1 - TimesSquare Capital Management's "U.S. Small Cap Growth Strategy" reported a gross return of 2.26% and a net return of 2.01% for Q3 2025, significantly underperforming the Russell 2000 Growth Index, which returned 12.19% [1] - All asset classes except fixed income outside the U.S. posted positive returns during the quarter [1] - The fund's top five holdings were highlighted as key investment picks for 2025 [1] Group 2 - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is a clinical-stage biopharmaceutical company that experienced a one-month return of -9.58% and a 52-week loss of 2.16%, with a market capitalization of $2.429 billion as of January 5, 2026 [2] - TimesSquare Capital added to its holdings in Soleno Therapeutics as shares pulled back by -19%, believing that allegations regarding the safety of its Vykat treatment for Prader-Willi Syndrome were inaccurate or exaggerated [3] - Soleno Therapeutics' net revenue more than doubled to $66 million in Q3 2025 compared to Q2 2025, with an increase in hedge fund interest from 52 to 58 portfolios [4]

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 Viewpoint - Kirby McInerney LLP is investigating potential claims against Soleno Therapeutics, Inc. regarding possible violations of federal securities laws or unlawful business practices [1] Group 1: Company Overview - Soleno Therapeutics, Inc. is under scrutiny following a report by Scorpion Capital that criticized its only product, Vykat XR, labeling it as overpriced and potentially unsafe for children [2] - The company's stock price experienced significant declines following negative reports and disclosures about Vykat XR, with a drop of approximately 7.41% on August 15, 2025, and a further decline of about 26.59% on November 5, 2025 [2][3] Group 2: Financial Impact - Following the Scorpion Capital report, Soleno's share price fell from $77.36 to $71.64, a decrease of $5.73 per share [2] - On November 4, 2025, Soleno disclosed a discontinuation rate of approximately 8% for Vykat XR due to adverse effects, which contributed to a further decline in share price from $63.85 to $46.87, a drop of $16.98 per share [3]

Core Insights - Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases, currently not generating significant revenue [1] - The company operates in a sector characterized by a focus on research and development rather than immediate profitability [5] Financial Metrics - Soleno's Return on Invested Capital (ROIC) is -15.74%, with a Weighted Average Cost of Capital (WACC) of 4.67%, resulting in a ROIC to WACC ratio of -3.37, indicating it is not generating returns that exceed its cost of capital [2] - In comparison, Akari Therapeutics has a ROIC of -64.44% and a WACC of 3.75%, leading to a ROIC to WACC ratio of -17.18, while Leap Therapeutics shows a ROIC of -37.62% and a WACC of 4.69, with a ratio of -8.02 [3] - Tenax Therapeutics has the highest ROIC to WACC ratio among peers at -4.39, despite a ROIC of -48.59% and a WACC of 11.07, suggesting it is relatively closer to covering its cost of capital [4] Industry Overview - All companies in the peer group, including Soleno Therapeutics, are experiencing negative ROIC, which is typical for clinical-stage biopharmaceutical companies in the investment phase [5]

Core Viewpoint - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is identified as a promising investment opportunity in the healthcare sector, with a consensus Buy rating from analysts and significant upside potential [1][2]. Analyst Ratings - All 13 analysts covering Soleno Therapeutics have assigned a 'Buy' or equivalent rating, indicating strong market confidence [1]. - Kristen Kluska from Cantor Fitzgerald maintains a 'Buy' rating with a price target of $123, while Kate Dellorusso from LifeSci Capital also holds a 'Buy' rating with a target of $110 [2]. - Wells Fargo's Derek Archila has reduced his price target to $106 from $123 but retains an 'Overweight' rating, citing the potential of Vykat XR as a significant drug for Prader-Willi syndrome [3]. - Wolfe Research initiated coverage with an 'Outperform' rating and a price target of $75, suggesting a nearly 44% upside from the current price, driven by the recent FDA approval of Vykat XR [3]. Company Overview - Soleno Therapeutics, Inc. is a California-based clinical-stage biopharmaceutical company founded in 1999, focusing on novel therapeutics for serious illnesses, specifically offering Diazoxide Choline Extended-Release tablets [4].