Core Viewpoint - Robbins Geller Rudman & Dowd LLP is investigating potential violations of U.S. federal securities laws involving Soleno Therapeutics, Inc., focusing on whether the company and its executives made false or misleading statements or failed to disclose material information to investors [1]. Company Overview - Soleno Therapeutics announced FDA approval for VYKAT XR (diazoxide choline) extended-release tablets on March 26, 2025, for treating hyperphagia in individuals aged 4 and older with Prader-Willi syndrome [3]. Recent Developments - During a quarterly earnings call on November 4, 2025, Soleno disclosed that the discontinuation rate of VYKAT XR due to adverse effects was approximately 8% at the end of Q3 2025. The CEO acknowledged a disruption in the product's launch trajectory following a short seller report in mid-August, which led to a decrease in start forms and an increase in discontinuations for non-serious adverse events. Following this announcement, Soleno's share price dropped by over 26% [4].

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 - The Portnoy Law Firm has initiated an investigation into potential securities fraud involving Soleno Therapeutics, Inc. and may file a class action lawsuit on behalf of investors [1][2]. Company Developments - On March 26, 2025, Soleno Therapeutics announced FDA approval for VYKAT XR (diazoxide choline) extended-release tablets aimed at treating hyperphagia in individuals with Prader-Willi syndrome aged 4 and older [3]. - During a quarterly earnings call on November 4, 2025, Soleno disclosed that the discontinuation rate for VYKAT XR due to adverse effects was approximately 8% by the end of Q3 fiscal 2025 [3]. - CEO Anish Bhatnagar acknowledged a disruption in the launch trajectory of VYKAT XR following a short seller report released in mid-August, which resulted in a decrease in start forms and an increase in discontinuations for non-serious adverse events [3]. - Following these developments, Soleno's share price experienced a decline of over 26% [3].

Summary of Soleno Therapeutics Conference Call Company Overview - **Company**: Soleno Therapeutics (NasdaqCM:SLNO) - **Conference Date**: November 12, 2025 - **Key Speakers**: Anish Bhatnagar (CEO), Jim Mackaness (CFO) Key Points Financial Performance - Q3 revenues reached **$66 million**, doubling from Q2, with **397 start forms** submitted [2][3] - The company is **profitable** and covers over **130 million lives** [2] - A **stock buyback** was initiated, indicating management believes the market undervalues the company [2][18] Market Dynamics - Initial patient script growth was strong, but there are indications of flattening in Q4, which is considered normal [3][4] - The company aims to capture **10% of the Total Addressable Market (TAM)** of **10,000 patients** within the first six months post-launch, with expectations to reach **20%** by next year [4][8][10] - The company anticipates continued **net patient growth** despite some fluctuations due to seasonal factors [5][6] Patient Discontinuation Rates - Discontinuation rates are currently between **8% to 10%**, with expectations to stabilize around **15%** based on clinical data [21][31] - Most discontinuations are due to non-serious adverse events, with a focus on improving patient adherence through education [21][22][32] Prescriber Engagement - There is a strong focus on **physician education** to improve prescribing practices, especially among less experienced doctors [26] - High-volume prescribers are not reaching capacity, indicating room for growth in patient prescriptions [29][30] Safety and Efficacy - The safety profile in the real world appears to be better than in clinical trials, with lower rates of adverse events reported [42][44] - Anecdotal evidence suggests positive efficacy outcomes, with patients experiencing significant improvements in their conditions [39][40] Market Access and Reimbursement - The company has achieved broad coverage, with **over 130 million lives** covered and successful reimbursement from various channels [48] - Reauthorizations are occurring, primarily based on physician and caregiver attestations [49][50] Future Outlook - The company is preparing for potential approval in the EU, with approximately **9,500 diagnosed patients** in the region [62] - There is ongoing interest in potential partnerships in the EU, but the company is also equipped to launch independently [65] - The competitive landscape remains open, with limited successful alternatives in the market for PWS [68] Strategic Focus - The company is focused on both organic and inorganic growth strategies moving forward [69] - Profitability is expected to be maintained while judicious investments are made in the commercial side of the business [70] Additional Insights - The company is actively engaging with patient advocacy groups and the broader community to gather feedback and improve treatment logistics [46] - There is a recognition of the need for ongoing education for both prescribers and caregivers to enhance treatment adherence and patient outcomes [32][26]

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 Insights - U.S. stocks showed mixed performance, with the Dow Jones index increasing by over 100 points on Tuesday [1] Company Performance - PubMatic Inc reported third-quarter earnings of 3 cents per share, surpassing the analyst consensus estimate of a loss of 10 cents per share, and quarterly sales of $67.960 million, exceeding the estimate of $63.768 million [1] - PubMatic shares surged by 33.2% to $10.19 following the positive earnings report [2] - Surmodics Inc experienced a gain of 49.3% to $40.85 after a court denied the FTC's attempt to block GTCR's acquisition [4] - enGene Holdings Inc's shares rose by 36.4% to $8.20 after reporting a 63% complete response rate in its Phase 2 LEGEND study [4] - Energy Vault Holdings Inc's stock increased by 33.1% to $4.72 following its third-quarter results [4] - RealReal Inc's shares climbed by 25.6% to $14.08 after reporting better-than-expected third-quarter results and raising its FY25 sales guidance [4] - Hallador Energy Co reported better-than-expected quarterly sales, leading to a 19.3% increase in its stock price to $23.87 [4] - BigBear.ai Holdings Inc's shares rose by 17.3% to $6.71 after announcing better-than-expected quarterly results and the acquisition of Ask Sage [4] - Paramount Skydance Corp's stock gained 10.9% to $16.92 after reporting third-quarter results and issuing optimistic fourth-quarter sales guidance [4] - Clearwater Analytics Holdings Inc's shares increased by 9.3% to $18.24 [4] - Rocket Lab Corp's stock rose by 8.3% to $56.27 after reporting better-than-expected third-quarter results and issuing positive fourth-quarter sales guidance [4] - Viasat Inc's shares gained 8.1% to $39.96 after an upgrade from JP Morgan analyst Philip Cusick, who raised the price target from $23 to $50 [4] - Soleno Therapeutics Inc's stock rose by 6.7% to $49.42 after announcing a $100 million accelerated share repurchase plan [4]

Summary of Soleno Therapeutics FY Conference Call Company Overview - **Company**: Soleno Therapeutics (NasdaqCM: SLNO) - **Industry**: Healthcare, specifically focusing on treatments for Prader-Willi Syndrome (PWS) and hyperphagia Key Financial Highlights - **Revenue**: Doubled to **$66 million** in the latest quarter [6] - **Cash Flow**: Achieved cash flow positive status [6] - **Market Share**: Captured **10%** of the total addressable market (TAM) within the first six months of launch [8][9] Core Insights and Arguments - **Market Expectations**: There was a disconnect between market expectations and actual performance, with investors expecting more immediate results from start forms [6][7] - **Start Forms Cadence**: Anticipated a steady increase in start forms over time, with normalization observed after an initial bullish phase [8][11] - **Long-term Market Potential**: The drug is projected to become a **billion-dollar** product in the near future [9] - **Buyback Program**: Announced a **$100 million** buyback program due to perceived undervaluation of the company's stock [10] Patient and Physician Engagement - **Discontinuation Rates**: Most discontinuations occur during the initial titration phase, often due to side effects such as peripheral edema and hyperglycemia [14][15] - **Education Initiatives**: Emphasis on educating both physicians and families to improve treatment adherence and understanding of the drug [16][17] - **Real-world Efficacy**: Maximal effects of the drug may take **six to nine months** to manifest, with early signs of efficacy being meaningful for patients [18] Market Dynamics - **Comorbidities Awareness**: Increased recognition among healthcare providers regarding the complexity of PWS and the need for careful patient management [20][24] - **Physician Education**: Ongoing efforts to enhance physician education through peer-to-peer interactions and expert consultations [32] European Market Strategy - **Regulatory Process**: Engaged with the European Medicines Agency (EMA) and expects a decision by **Q2** of the following year [35][37] - **Launch Preparation**: Plans to potentially launch in Europe independently, starting with Germany, while also considering partnerships [38] Coverage and Access - **Insurance Coverage**: Expanded coverage to **132 million lives**, with expectations to reach **80%** coverage in 12 to 18 months post-launch [42] - **Payment Success**: Positive payment trends observed from state Medicaid programs and major pharmacy benefit managers [42] Additional Considerations - **Patient Weight Trends**: Anticipated that patient weight may trend higher in the commercial setting compared to clinical trials [43] - **Dosing Strategy**: Patients will be titrated based on weight bands, with higher doses expected for larger patients [45] This summary encapsulates the key points discussed during the Soleno Therapeutics FY Conference Call, highlighting the company's performance, market strategy, and ongoing efforts to engage with healthcare providers and patients.

Core Insights - Soleno Therapeutics has authorized a $100 million share repurchase and entered into an Accelerated Share Repurchase Agreement with Jefferies LLC [1][2] - The company achieved profitability in Q3 2025 and believes its future cash generation potential is undervalued by the market [2] Financial Actions - The initial payment under the ASR agreement will be $100 million, with an initial delivery of approximately 1,511,553 shares based on the closing price on November 10, 2025 [2] - The final number of shares repurchased will depend on the average volume-weighted price during the transaction period and will be subject to adjustments [2] Product Information - Soleno's first commercial product, VYKAT XR, is an oral treatment for hyperphagia in patients with Prader-Willi syndrome, targeting both adults and children aged 4 and older [4]

Company Overview - Soleno Therapeutics is a biopharmaceutical company focused on developing innovative treatments for rare diseases [3]. Allegations and Impact - The FDA authorized Soleno's VYKAT XR (diazoxide choline) on March 26, 2025, for treating hyperphagia in patients aged four years and older with Prader-Willi syndrome [4]. - By November 4, 2025, Soleno reported an 8% discontinuation rate of the drug due to side effects and indicated that a short-seller report from mid-August had delayed the drug's rollout [4]. - Following these developments, Soleno's stock price experienced a decline of over 26% [4]. Legal Investigation - Edelson Lechtzin LLP is investigating potential violations of federal securities laws related to Soleno, stemming from allegations of providing misleading business information to investors [1].

Company Overview - Soleno Therapeutics, Inc. (NASDAQ: SLNO) is under investigation for potential violations of U.S. federal securities laws, focusing on whether the company and its executives made false or misleading statements or failed to disclose material information to investors [1][2]. Recent Developments - On March 26, 2025, Soleno announced FDA approval for VYKAT XR (diazoxide choline) extended-release tablets, intended for treating hyperphagia in individuals with Prader-Willi syndrome aged 4 and older [3]. - During a quarterly earnings call on November 4, 2025, Soleno disclosed a discontinuation rate of approximately 8% for VYKAT XR due to adverse effects by the end of Q3 2025. The CEO acknowledged a disruption in the product's launch trajectory following a short seller report released in mid-August, which led to a decrease in start forms and an increase in discontinuations for non-serious adverse events [4]. Market Reaction - Following the earnings call and the revelation of the discontinuation rate, Soleno's share price experienced a decline of over 26% [4].