Company Overview - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is recognized as one of the best stocks to buy for the next three months according to hedge funds [1] - The company specializes in developing and commercializing novel treatments for rare diseases [3] Recent Developments - The company announced the commercial launch of VYKAT XR, the first FDA-approved treatment for hyperphagia in Prader-Willi Syndrome [2] - Since the approval, Soleno has received 646 patient start forms from 295 unique prescribers, covering over 100 million insured lives in the US [2] - Soleno is also pursuing marketing approval for VYKAT XR in the European Union through the European Medicines Agency [2] - The company has presented clinical data at major medical conferences to enhance awareness regarding the drug's safety and efficacy [2] Analyst Ratings - Analysts have shown a bullish outlook on the stock, with TD Cowen analyst Tyler Van Buren maintaining a Buy rating and a price target of $120 [3] - Oppenheimer's Leland Gershell also reiterated a Buy rating with a price target of $110 [3]

Accessibility StatementSkip Navigation NEW YORK, Sept. 5, 2025 /PRNewswire/ -- Why:Â Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Soleno Therapeutics, Inc. (NASDAQ: SLNO) resulting from allegations that Soleno Therapeutics may have issued materially misleading business information to the investing public. So What: If you purchased Soleno Therapeutics securities you may be entitled to compensation without payment of ...

Core Insights - Soleno Therapeutics has recently received FDA approval for its first drug, VYKAT, targeting Prader-Willi Syndrome, and has successfully launched the product [4]. Company Overview - Soleno Therapeutics operates in the rare disease sector, focusing on Prader-Willi Syndrome with a single approved asset [4]. - The company reported a strong launch performance, achieving 646 start forms and engaging 295 prescribers within three months post-launch, exceeding initial expectations [4].

Financial Data and Key Metrics Changes - The company received FDA approval for its first drug, VYKAT XR, for Prader-Willi syndrome at the end of March, followed by a successful launch with 646 start forms and 295 prescribers in the first three months, exceeding expectations [4][10] - The discontinuation rate for adverse events was about 5.2%, which is consistent with the clinical trial population, indicating a surprisingly low rate compared to typical transitions from clinical to commercial settings [18][21] Business Line Data and Key Metrics Changes - The launch of VYKAT XR has shown strong initial uptake, with a significant number of prescribers and start forms, indicating a positive reception in the market [4][26] - The patient demographic has shifted, with a majority of new patients being between 4 and 26 years of age, and they are somewhat heavier than the clinical trial population, which may lead to more comorbidities [15][30] Market Data and Key Metrics Changes - The total addressable market (TAM) in the U.S. is estimated at 10,000 patients, with about 12,500 patients identified based on claims analysis [34] - In Europe, the prevalence of Prader-Willi syndrome is similar to that in the U.S., with an estimated 9,000 patients, and the company is expecting a year for approval following its filing in early May [38][39] Company Strategy and Development Direction - The company aims to maintain a strong commercial focus on the launch of VYKAT XR while exploring potential partnerships for European commercialization [41] - There is an emphasis on lifecycle management and patent protection, with several families of patents in place to extend the product's market exclusivity [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's safety profile and the ongoing education of healthcare providers regarding patient monitoring and titration [16][17] - The company anticipates a slow and steady increase in patient uptake over time, rather than exponential growth, as the market stabilizes [25][26] Other Important Information - The company has a strong cash position of over $500 million, which supports its operational and expansion plans [55][56] - There is ongoing development of marketing materials and educational resources for healthcare providers and families to ensure proper drug administration and monitoring [17] Q&A Session Summary Question: What are the early efficacy and safety observations from patients on VYKAT XR? - Management noted that while the safety profile remains similar to clinical trials, some patients with more comorbidities have experienced more severe side effects [6][7] Question: How is the physician community responding to the drug? - The embrace of the drug is evident, with a high number of prescribers and positive feedback from key opinion leaders [12] Question: What is the expected trajectory for the drug's launch? - Management indicated that while initial numbers are strong, they expect a more moderate growth rate moving forward [25][26] Question: What is the company's strategy regarding European commercialization? - The company is considering both self-commercialization and potential partnerships, with ongoing hiring and market development in Europe [41] Question: How does the company view the competitive landscape for Prader-Willi syndrome treatments? - Management believes there is room for multiple treatments in the market, as no single drug will work for all patients [44] Question: What is the company's approach to intellectual property and lifecycle management? - The company has multiple patent families in place and is actively pursuing additional options for IP protection [51][52]

Financial Data and Key Metrics Changes - Soleno Therapeutics received FDA approval for its first drug, VYKAT XR, for Prader-Willi syndrome at the end of March 2025, with a successful launch shortly thereafter [4] - In Q2, the company reported 646 start forms and 295 prescribers, exceeding expectations [4][10] - The discontinuation rate for adverse events was about 5.2%, which is consistent with the clinical trial population [18] Business Line Data and Key Metrics Changes - The launch of VYKAT XR has been successful, with a significant number of prescribers and start forms indicating strong initial uptake [4][10] - The patient population primarily consists of younger individuals aged 4 to 26, who are heavier than those in clinical trials, leading to potential challenges in monitoring [14][15] Market Data and Key Metrics Changes - The total addressable market (TAM) for Prader-Willi syndrome in the U.S. is estimated at 10,000 patients, with 12,500 patients identified based on claims analysis [36] - In Europe, the prevalence of Prader-Willi syndrome is similar to that in the U.S., with an estimated 9,000 patients across the EU4 plus the UK [40] Company Strategy and Development Direction - The company aims to maintain a strong commercial focus on the launch of VYKAT XR while exploring potential partnerships for European commercialization [43][55] - Soleno Therapeutics is open to exploring additional assets or mechanisms of action (MOAs) related to Prader-Willi syndrome in the future [54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's safety profile and the ongoing education of healthcare providers regarding monitoring and titration [16][17] - The company anticipates a slow and steady increase in patient uptake over time, rather than exponential growth [27][28] Other Important Information - The company has a robust intellectual property (IP) strategy, with multiple patent families and potential extensions into the late 2030s [52] - Management highlighted the importance of long-term safety data, which provides a competitive advantage over new entrants in the market [48][49] Q&A Session Summary Question: What is the launch trajectory for VYKAT XR? - Management indicated that while initial uptake has been strong, it is not sustainable at the same rate, and a moderate growth trajectory is expected [27][28] Question: How is the physician community responding to VYKAT XR? - The embrace of the drug is significant, with many prescribers being previously unknown to the company, indicating a broad acceptance [12] Question: What are the expectations for payer coverage and reauthorizations? - Currently, there have been no reauthorizations, and the focus will be on whether the drug is effective for patients [22][23] Question: What is the competitive landscape for Prader-Willi syndrome treatments? - Management believes there is room for multiple treatments in the market, as no single drug will work for everyone [44][45] Question: What is the company's strategy regarding commercialization in Europe? - The company is considering both self-commercialization and potential partnerships, with ongoing discussions in this area [43] Question: How does the company plan to manage its cash and commercial footprint? - The company is well-capitalized with over $500 million in cash, allowing for continued investment in the launch and potential expansion [56][57]

Company Overview - Soleno Therapeutics operates in the rare disease space and has recently launched a drug for Prader-Willi syndrome (PWS) in the U.S. [3] - The company is also in the process of filing for approval in Europe and exploring additional opportunities for the drug [3] Market Dynamics - Prior to the approval of Vykat XR, patients with PWS had limited treatment options, primarily focusing on growth hormone management [4] - The introduction of Vykat XR is expected to change the frequency of patient visits to physicians, as the availability of this drug provides a new treatment avenue [4]

Summary of Soleno Therapeutics (SLNO) Conference Call Company Overview - **Company**: Soleno Therapeutics - **Focus**: Rare disease space, specifically Prader-Willi syndrome (PWS) - **Recent Development**: Recently approved drug VICAT XR launched in the US, with filings in Europe ongoing [4][48] Core Points and Arguments - **Patient Interaction**: Prior to VICAT XR, younger patients had 4-6 healthcare provider interactions annually, while older patients had about 2. With the new drug, initial interactions may increase but stabilize over time [5] - **Prescriber Dynamics**: 646 patient start forms were submitted with 295 prescribers, indicating that many prescriptions are coming from non-KOL (Key Opinion Leader) providers due to accessibility issues [7][8] - **Patient Evaluation**: Physicians evaluate patients before prescribing, requiring minimal labs (e.g., hemoglobin A1c, fasting glucose) [10] - **Long-term Benefits**: Key benefits observed include improvements in hyperphagia, enhanced cognitive function, and better management of PWS-related behaviors [12][13] - **Safety Profile**: Side effects such as hyperglycemia and peripheral edema are consistent with clinical trials, but real-world patients may have more comorbidities, potentially increasing side effect severity [20][21] - **Monitoring and Education**: Emphasis on educating physicians about the drug's effects, which may take 6-9 months to fully manifest [18] - **Reimbursement Dynamics**: Initial reimbursement has been positive, with 100 million lives covered, but challenges remain, especially with Medicaid and Medicare [31][32] Additional Insights - **Market Opportunity in Europe**: The EU market for PWS is potentially larger than initially thought, with structured care systems in countries like France and Germany [44][46] - **Financial Position**: The company is in a strong financial situation post-funding, with expectations of cash flow positivity even before financing [49][50] - **Future Outlook**: Caution advised against overestimating growth based on initial strong performance; ongoing monitoring of patient starts and reimbursement processes is essential [36][37] Conclusion - **Investment Potential**: The unmet need in the PWS market presents a significant opportunity for Soleno Therapeutics, with a favorable risk-reward profile for the VICAT XR drug [28][46]

Group 1 - Soleno Therapeutics, Inc. will participate in several investor conferences in September 2025, including the Cantor Global Healthcare Conference and Wells Fargo Healthcare Conference [1] - The presentation format for all listed conferences will be a fireside chat, allowing for an interactive discussion [1] - Replays of the Cantor and Wells Fargo events will be available on the company's website for investors [1] Group 2 - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases [2] - The company's first commercial product, VYKAT™ XR, is an oral treatment for hyperphagia in individuals with Prader-Willi syndrome, available for adults and children aged 4 and older [2] - For further information, the company provides resources on its website [2]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Soleno Therapeutics, Inc. due to allegations of violations of federal securities laws and unlawful business practices following a negative report on its product Vykat XR [2][3]. Group 1: Company Overview - Soleno Therapeutics, Inc. (NASDAQ: SLNO) is facing scrutiny after a report from Scorpion Capital labeled its only product, Vykat XR, as overpriced and potentially unsafe for children [3]. - Following the report's publication on August 15, 2025, Soleno's stock price dropped by $5.73 per share, representing a decline of 7.41%, closing at $71.63 per share [3]. Group 2: Legal Investigation - Bragar Eagel & Squire, P.C. is encouraging investors who suffered losses from Soleno's stock to contact them to discuss their legal rights and options [1][4]. - The law firm is specifically looking into whether Soleno has engaged in unlawful business practices that could have harmed investors [2].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Soleno Therapeutics, Inc. following a negative report on its product Vykat XR [1][2]. Group 1: Company Overview - Soleno Therapeutics, Inc. is publicly traded on NASDAQ under the ticker SLNO [1]. - The company's only product, Vykat XR, has been criticized for being overpriced and potentially unsafe for children [2]. Group 2: Legal Investigation - Pomerantz LLP is representing investors in the investigation concerning Soleno's officers and directors [1]. - The firm has a long history in corporate and securities class litigation, having recovered significant damages for victims of securities fraud [3]. Group 3: Market Reaction - Following the publication of Scorpion Capital's report on August 15, 2025, Soleno's stock price dropped by $5.73 per share, a decline of 7.41%, closing at $71.63 per share [2].