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Soleno Therapeutics, Inc. (NASDAQ:SLNO) Financial Analysis
Financial Modeling Prep· 2025-12-14 17:00
Soleno Therapeutics, Inc. (NASDAQ:SLNO) is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases. As a company in the early stages of development, Soleno is not yet generating significant revenue, which is reflected in its financial metrics. The company's peers include other clinical-stage biopharmaceutical firms like Akari Therapeutics, Leap Therapeutics, Tenax Therapeutics, Achieve Life Sciences, and Avenue Therapeutics.Soleno's Return on Invested Capital (ROIC) is ...
Is Soleno Therapeutics, Inc. (SLNO) The Cheap Healthcare Stock To Buy Heading Into 2026?
Yahoo Finance· 2025-12-10 15:32
Soleno Therapeutics, Inc. (NASDAQ:SLNO) is among the cheap healthcare stocks to buy heading into 2026. As of December 7, Soleno Therapeutics, Inc. (NASDAQ:SLNO) has a consensus Buy rating, as all 13 analysts covering the stock have assigned a ‘Buy’ or equivalent rating. With a median price of $110, the stock boasts an upside potential of around 114%. On November 5, Kristen Kluska, an analyst at Cantor Fitzgerald, reiterated a ‘Buy’ rating on Soleno Therapeutics, Inc. (SLNO), with a price target of $123. S ...
Soleno Therapeutics (NasdaqCM:SLNO) FY Conference Transcript
2025-12-04 15:02
Summary of Soleno Therapeutics FY Conference Call Company Overview - **Company**: Soleno Therapeutics (NasdaqCM:SLNO) - **Product**: ViCAT, a treatment for hyperphagia and Prader-Willi Syndrome (PWS) Key Industry Insights - **Market Opportunity**: ViCAT addresses a significant unmet need in treating hyperphagia and PWS, with a total addressable market (TAM) of approximately 10,000 patients, of which 12,500 are diagnosed [4][30] - **Launch Performance**: The company achieved 10% of its TAM, equating to about 1,000 patients, within the first six months of ViCAT's launch [4][16] - **Future Projections**: Analysts project peak sales for ViCAT to reach $463 million by 2026, with potential to exceed $1 billion in subsequent years [8][26] Financial Metrics - **Quarterly Expectations**: Current consensus estimates for Q4 revenue are at $83.3 million, although the company refrains from providing specific revenue guidance [6][7] - **Patient Metrics**: In Q3, the company reported 1,043 start forms and 764 active patients, indicating a conversion process from start forms to active prescriptions [16][17] Market Access and Reimbursement - **Access Success**: ViCAT has achieved coverage for over 130 million lives, with reimbursement from more than 40 states and favorable policies from the three largest pharmacy benefit managers (PBMs) [13][14] - **Challenges**: While access is generally positive, there are occasional payer issues that need to be addressed [14] Physician Engagement and Education - **KOL Engagement**: The company emphasizes the importance of deep engagement with key opinion leaders (KOLs) and has successfully reached over 500 prescribers in the first six months [10][30] - **Educational Initiatives**: Soleno has implemented various educational programs for physicians, including webinars and peer-to-peer discussions, to enhance understanding of PWS and ViCAT [28][29] Patient and Caregiver Support - **Patient Stories**: Positive patient experiences are being shared through a dedicated website, highlighting the impact of ViCAT on quality of life [40][41] - **Support Programs**: The Soleno Pace Program provides real-time support for patients and caregivers, ensuring quick communication and assistance [44] Regulatory Considerations - **Adverse Events Monitoring**: The company is monitoring adverse events reported in the FAERS database, noting that these events are consistent with the known safety profile of ViCAT [47][50] - **European Regulatory Filing**: Soleno is in the process of responding to Day 120 Questions from the European Medicines Agency, indicating ongoing regulatory efforts [55] Conclusion - **Overall Outlook**: The launch of ViCAT is progressing well, with strong market access, positive patient feedback, and a robust educational framework for physicians. The company remains focused on addressing any challenges while capitalizing on the significant market opportunity presented by PWS and hyperphagia [4][8][14]
Soleno Turns First Profit on $66 Million in Revenue — Is This Why One Investor Just Made an $87 Million Bet?
The Motley Fool· 2025-12-04 00:02
Soleno just turned profitable for the first time—right as a major fund made its move.Connecticut-based fund Braidwell initiated a new position in Soleno Therapeutics (SLNO +5.41%) during the third quarter, adding 1.3 million shares worth about $86.7 million, according to a November 14 SEC filing.What HappenedAccording to a Securities and Exchange Commission (SEC) filing dated November 14, Braidwell disclosed a new equity position in Soleno Therapeutics (SLNO +5.41%). The fund acquired nearly 1.3 million sha ...
Soleno Therapeutics Announces the Passing of Board Member William G. Harris
Globenewswire· 2025-12-03 21:05
Core Points - Soleno Therapeutics announced the passing of William G. "Bill" Harris, a long-serving member of its Board of Directors and Chairman of the Audit Committee since June 2014 [1][2] - Dr. Anish Bhatnagar, CEO and Chairman of the Board, expressed condolences and highlighted Mr. Harris's integrity and contributions to the company during challenging times [2] - Andrew Sinclair is expected to succeed Mr. Harris as Chair of the Audit Committee, qualifying as an "audit committee financial expert" as per SEC and Nasdaq rules [3] Company Overview - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases [4] - The company's first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, was approved by the FDA on March 26, 2025, for treating hyperphagia in individuals with Prader-Willi syndrome aged 4 and older [4]
Analyst Dismisses ViCAT XR Safety Fears, Expects Strong Growth Despite Recent Stock Weakness
Yahoo Finance· 2025-11-30 05:26
Soleno Therapeutics Inc. (NASDAQ:SLNO) is one of the best upside stocks to buy now. On November 18, Wolfe Research analyst Kalpit Patel initiated coverage of Soleno Therapeutics with an Outperform rating and $75 price target. The stock price has been weak recently due to a sequential slowdown in the number of new patients starting treatment (ViCAT XR). However, Patel noted that the firm’s latest survey data indicates concerns about the treatment’s safety are overblown, and the underlying trend for its use ...
Soleno Therapeutics (SLNO) Reports Strong Q3 Earnings Despite VYKAT XR Safety Concerns
Yahoo Finance· 2025-11-25 13:39
Core Insights - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is identified as one of the most oversold biotech stocks, reporting third-quarter adjusted earnings of $0.47 per share, significantly above analyst expectations of $0.05 per share, with revenue reaching $66 million [1][2]. Financial Performance - The company reported adjusted earnings of $0.47 per share for Q3, surpassing the consensus estimate of $0.05 per share [1]. - Revenue for the quarter was $66 million, which also exceeded analyst expectations [1]. Stock Performance and Market Reaction - Despite strong financial results, the stock price fell sharply due to investor concerns regarding the discontinuation rates for VYKAT XR, a treatment for hyperphagia in patients with Prader-Willi syndrome [2]. - Piper Sandler reaffirmed an Overweight rating and a price target of $145 for Soleno Therapeutics, suggesting that the stock had been oversold due to recent safety concerns related to VYKAT XR [3]. Analyst Opinions - Piper Sandler maintained optimism regarding the ongoing launch of VYKAT XR, viewing the stock's decline as a "compelling buying opportunity" for investors [4]. - The firm attributed the stock's decline to safety concerns raised in the FDA Adverse Event Reporting System and a brief thesis published in August [3]. Company Overview - Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics for rare diseases [4].
Soleno Therapeutics to Present at the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-24 13:00
Core Insights - Soleno Therapeutics, Inc. is participating in the Piper Sandler 37 Healthcare Conference on December 4, 2025, with CEO Anish Bhatnagar scheduled for a fireside chat [1] Company Overview - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases [3] - The company's first commercial product is VYKAT™ XR (diazoxide choline) extended-release tablets, designed for treating hyperphagia in individuals with Prader-Willi syndrome aged 4 years and older [3]
Wolfe Research Initiates Soleno Therapeutics (SLNO) Coverage with Outperform Rating, $75 PT, Dismisses Patient Slowdown Concerns
Yahoo Finance· 2025-11-21 10:22
Core Viewpoint - Soleno Therapeutics Inc. is identified as a promising investment opportunity despite recent market challenges, with an Outperform rating and a price target of $75 set by Wolfe Research analyst Kalpit Patel [1][3]. Financial Performance - In Q3 2025, Soleno Therapeutics reported a net income of $26 million, significantly boosted by increased sales of its drug ViCAT XR, with total net revenue more than doubling from Q2 to reach $66 million [3]. - The company has achieved broad market adoption for ViCAT XR, securing coverage for approximately 132 million lives and currently supporting 764 active patients with reimbursed claims [3]. Market Outlook - Patel's analysis indicates a favorable directional trend for patient utilization over the next 1-2 years, which contradicts the market's concerns regarding a slowdown in new patient starts [2][3]. - The recent weakness in the company's stock is attributed to perceived safety concerns related to the slowdown, which Patel considers to be exaggerated [1][2].
Soleno Therapeutics (NasdaqCM:SLNO) 2025 Conference Transcript
2025-11-18 18:02
Summary of Soleno Therapeutics Conference Call Company Overview - **Company**: Soleno Therapeutics (NasdaqCM: SLNO) - **Industry**: Rare Disease Pharmaceuticals - **Product**: VICAT XR, the first FDA-approved drug for Prader Willi syndrome [2][15] Core Points and Arguments - **Market Opportunity**: The market for Prader Willi syndrome is a multibillion-dollar total addressable market (TAM) with approximately 12,000 to 15,000 patients in the U.S. and around 400,000 globally [2][3][8] - **Disease Characteristics**: Prader Willi syndrome is characterized by hyperphagia, leading to severe health complications and a significantly reduced life expectancy, often due to respiratory or cardiovascular issues [3][8][9] - **Clinical Development**: The clinical program for VICAT XR included multiple studies, with the pivotal Phase III study (C601) initially not meeting its primary endpoint due to pandemic-related data skewing. Subsequent analyses showed significant efficacy [12][13][14] - **Regulatory Approval**: VICAT XR was approved for treating hyperphagia in patients aged four years and older with Prader Willi syndrome, marking it as the first treatment available for this condition [15][16] Financial Performance - **Financial Health**: As of September 30, the company reported $550 million in cash, with a net revenue of $66 million and a positive net income of $26 million for the third quarter [31] - **Shareholder Returns**: Announced a $100 million accelerated share repurchase program [31] Commercial Strategy - **Launch Success**: Over 1,000 start forms submitted, representing 10% of the TAM, with 494 unique prescribers and 764 active patients on the drug [18] - **Education and Advocacy**: Engaged with advocacy organizations and healthcare providers to educate about the disease and treatment, leading to significant adoption [17][22] - **Reimbursement Landscape**: Coverage for over 130 million lives, with favorable reimbursement policies from major payers, indicating recognition of the unmet need [22][23] International Expansion - **European Market**: Approximately 9,500 patients identified in the EU4 plus UK, with a high unmet need similar to the U.S. [27][28] - **Regulatory Submission**: Submitted a Marketing Authorization Application (MAA) in Europe, with an expected approval decision around Q2 of the following year [29] Intellectual Property - **Patent Protection**: Strong IP portfolio with protections extending into the mid-2030s, including a recent patent related to treating hyperphagia [30] Additional Insights - **Patient Impact**: The drug has significantly improved the quality of life for patients, allowing for more normalcy in daily activities, such as travel [26][25] - **Community Engagement**: Ongoing efforts to support caregivers and patients through educational programs and community events [21][24] This summary encapsulates the key points discussed during the Soleno Therapeutics conference call, highlighting the company's strategic positioning, market potential, and commitment to addressing the needs of patients with Prader Willi syndrome.