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A focused biotech aiming to do for Prader-Willi Syndrome what Vertex Pharmaceuticals did for Cystic Fibrosis.

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• DCCR (Diazoxide Choline Extended-Release Tablets): An investigational oral drug candidate for the treatment of Prader-Willi Syndrome.

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Soleno Therapeutics (SLNO) - Major Customers

Soleno Therapeutics (SLNO) is a clinical-stage biopharmaceutical company. As of the current date, the company's primary focus is on the development of its lead product candidate, DCCR (Diazoxide Choline Extended-Release tablets), for the treatment of Prader-Willi Syndrome (PWS).

Soleno Therapeutics does not currently have any commercialized products approved for sale on the market. Consequently, the company does not have major customers in the traditional sense of companies or individuals purchasing its products. Their activities are centered on clinical development and seeking regulatory approval for DCCR.

Therefore, it is not applicable to list major customer companies or categories of individual customers served, as Soleno Therapeutics is not yet generating revenue from product sales.

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• Catalent, Inc. (Symbol: CTLT)
• Lonza Group AG (Symbol: LONN.SW)

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Anish Bhatnagar, MD, Chairman of the Board and Chief Executive Officer

Dr. Bhatnagar has served as Soleno's Chief Executive Officer since its inception in 2017 and also holds the position of Chairman of the Board. With nearly three decades of experience in the biopharmaceutical and medical device industries, his expertise encompasses the development of biologics, drugs, drug-device combinations, and diagnostic and therapeutic medical devices. Before leading Soleno, Dr. Bhatnagar was the Chief Executive Officer of Capnia, Inc. from February 2014 to March 2017, having held positions of increasing responsibility at Capnia since 2006. His earlier career included roles at Titan Pharmaceuticals, Inc. (2000-2006) and Coulter Pharmaceuticals, Inc. (1998-2000). He founded Soleno by acquiring a small company in Southern California. Dr. Bhatnagar has been involved in the development of several approved products, such as Bexxar, Probuphine, Serenz, and CoSense. He currently serves on the Boards of ImmuneEdge, a private company, and IndoUSrare, a non-profit organization.

James Mackaness, Chief Financial Officer

James Mackaness was appointed Chief Financial Officer of Soleno Therapeutics in 2020.

Meredith Manning, Chief Commercial Officer

Meredith Manning joined Soleno Therapeutics as Chief Commercial Officer in January 2024. She has experience as Chief Commercial Officer at Reata Pharmaceuticals for over seven years, during which the company achieved its first product approval and launch, followed by its acquisition by Biogen for $7.3 billion in September 2023. Prior to Reata, Ms. Manning was Vice President of Sales and part of the executive leadership team at Pharmacyclics, which launched a blockbuster hematology therapeutic and was subsequently acquired by AbbVie in 2015 for $21 billion.

Dairine Dempsey, PhD, Senior Vice President, Europe

Dr. Dempsey became Soleno's Senior Vice President, Europe in July 2025, after serving as Vice President, Europe since January 2024, and consulting for Soleno since January 2019. With over 20 years of experience in the pharmaceutical, biologic, and device industries, she previously founded and led the start-up phase of Open Orphan plc (now hVIVO plc), a company specializing in orphan drugs. Dr. Dempsey also served as Global Vice President, Strategic Regulatory Affairs at ICON plc.

Patricia C. Hirano, MPH, Senior Vice President, Regulatory Affairs

Patricia C. Hirano serves as Senior Vice President of Regulatory Affairs at Soleno Therapeutics, a position she has held since 2019. She is involved in global clinical development and post-marketing management of pharmaceutical products, including those for rare diseases.

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The key risks to Soleno Therapeutics (SLNO) primarily revolve around its sole commercialized product, VYKAT™ XR (Diazoxide Choline Extended-Release tablets), and the intensified scrutiny it faces.

1. Safety Concerns, Regulatory Scrutiny, and Potential Market Withdrawal of VYKAT™ XR: Soleno Therapeutics faces significant risks due to serious allegations regarding the safety and data integrity of its flagship product, VYKAT™ XR, a treatment for Prader-Willi syndrome. A detailed report by short-seller Scorpion Capital alleged "rapid pile-ups of reports of children hospitalized for potential heart failure" shortly after starting VYKAT™ XR, and raised questions about the scientific rigor of its clinical trials. Although the company and treating physician deemed a reported patient death unrelated to VYKAT™ XR, this event further fuels safety concerns and regulatory scrutiny. These issues could lead to adverse regulatory actions from the FDA, such as a black box warning, mandated additional trials, or even the withdrawal of the drug from the market, which would be catastrophic for the company. Ongoing legal investigations are also scrutinizing Soleno's disclosures concerning VYKAT™ XR's safety.
2. High Dependence on a Single Product and Limited Pipeline: Soleno Therapeutics is widely described as a "one-trick pony" due to its overwhelming reliance on VYKAT™ XR as its sole meaningful asset, pipeline, or scientific program. This makes the company's entire valuation and future viability highly vulnerable to any setbacks, commercial failures, or increased competition related to VYKAT™ XR. Furthermore, the core patent for VYKAT™ XR is reportedly set to expire as early as 2026, which could significantly impact the company's revenue streams and market position without a diversified pipeline to offset this loss.
3. Commercialization Challenges and Market Acceptance: The commercial launch of VYKAT™ XR has encountered challenges, including disappointing uptake and an increase in discontinuations due to non-serious adverse events. Soleno must successfully establish a robust commercial organization, achieve widespread market acceptance, and secure reliable manufacturing and distribution partnerships to ensure the drug's success. The company also faces potential competition from other therapies for Prader-Willi Syndrome, which could erode its first-mover advantage in the market. Questions raised about the integrity of clinical trial data and the company's alleged dependence on a "controversial physician" could further undermine market confidence and commercial prospects.

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The clear emerging threat to Soleno Therapeutics (SLNO) is the increasing investigation and potential use of glucagon-like peptide-1 (GLP-1) receptor agonists, and related multi-agonists like GLP-1/GIP, for the treatment of Prader-Willi Syndrome (PWS). While not yet approved specifically for PWS, these drugs are already widely successful in managing obesity and type 2 diabetes due to their significant effects on appetite suppression and weight loss. Several clinical trials and research initiatives are exploring their efficacy and safety in the PWS population. Given their established safety profiles and strong efficacy in related metabolic conditions, there is a clear potential for GLP-1 agonists to emerge as a competitive or even superior treatment option for hyperphagia and other symptoms in PWS, potentially challenging Soleno's DCCR (Diazoxide Choline Controlled Release) once it reaches the market.

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• Global Market: The global Prader-Willi Syndrome market size was estimated at USD 599.81 million in 2023 and is projected to grow to USD 1131.94 million by 2033, with a Compound Annual Growth Rate (CAGR) of 6.56%. Another estimate places the global market at US$ 633.56 million in 2024, expected to reach US$ 1,078.80 million by 2033, growing at a CAGR of 6.0%. VYKAT™ XR (formerly DCCR) accounted for the largest market share in 2023 within the hyperphagia treatment segment of the global Prader-Willi Syndrome market.
• U.S. Market: Approximately 20,000 individuals in the United States are estimated to have Prader-Willi Syndrome. Annual revenue for VYKAT™ XR in the U.S. is expected to reach $404 million by 2034.
• European Market (France, Germany, Italy, Spain, and U.K.): It is estimated that 9,500 people live with PWS across these five European countries. Soleno Therapeutics is pursuing European regulatory approval for VYKAT™ XR.
• 7MM Market (United States, EU4, and Japan): The market size for Prader-Willi Syndrome in these seven major markets reached USD 600 million in 2023 and is expected to increase by 2034.

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Soleno Therapeutics (SLNO) is poised for significant future revenue growth over the next 2-3 years, primarily driven by the following factors:

1. Continued Commercialization and Market Adoption of VYKAT™ XR in the U.S.: The successful U.S. launch and robust market adoption of VYKAT™ XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia in Prader-Willi Syndrome (PWS) patients is a key driver. Soleno Therapeutics reported a Q3 2025 revenue surge to $66 million, significantly exceeding estimates, largely due to VYKAT™ XR's success. The company has seen strong adoption, with 764 individuals actively treated and 397 patient start forms recorded in Q3 2025, and aims to continue its revenue growth through patient education and engagement. Analysts project significant growth for the drug, with some forecasting peak revenues of $2 billion.
2. Regulatory Approval and Market Expansion of DCCR in Europe: Soleno Therapeutics is actively pursuing regulatory approval for DCCR in Europe, currently addressing day 120 questions from the European Medicines Agency (EMA). Successful approval in the EU would substantially expand their addressable market, as there are an estimated 9,500 people with PWS in major European countries (France, Germany, Italy, Spain, and the U.K.). This international expansion is a priority and a key component of the company's forward-looking growth strategy.
3. Potential Expansion of DCCR to Other Genetic Obesities: Beyond its primary indication in PWS, Soleno is evaluating DCCR's potential as a treatment for pediatric patients with other genetic obesities, including SH2B1 deficiency, obesity associated with PCSK1 mutation (rs6232 variant), and SIM1 deficiency. If successful, this pipeline expansion could unlock new, larger markets for DCCR, offering additional avenues for revenue generation in the future.
4. Increasing Awareness and Diagnosis Rates of Prader-Willi Syndrome: The overall Prader-Willi Syndrome market is projected to grow, fueled by rising awareness and improved diagnosis rates. The PWS market is estimated to reach $1.59 billion by 2032, growing at a compound annual growth rate (CAGR) of 7.2% from 2025. As the first FDA-approved treatment for hyperphagia in PWS, VYKAT™ XR is well-positioned to capitalize on this expanding market and benefit from the increasing patient population seeking effective treatments.

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Share Repurchases

• Soleno Therapeutics' Board of Directors authorized a $100 million share repurchase plan.
• The company entered into an Accelerated Share Repurchase (ASR) agreement with Jefferies LLC to repurchase $100 million of its common stock.
• An initial delivery of approximately 1,511,553 shares was made based on the closing price on November 10, 2025, with the ASR anticipated to be completed in the first quarter of 2026.

Share Issuance

• On March 31, 2022, Soleno Therapeutics sold 2,666,666 shares of its common stock through an underwritten public offering.
• On September 28, 2023, Soleno priced an underwritten public offering of 3,000,000 shares of common stock at $20.00 per share, expecting gross proceeds of approximately $60.0 million.
• A concurrent private placement of common stock and/or pre-funded warrants was also part of the September 2023 offering.

Inbound Investments

• The company conducted a public offering and concurrent private placement in September 2023, which was expected to generate approximately $60.0 million in gross proceeds from the public offering component.

Capital Expenditures

• Capital expenditures for the last 12 months (ending September 2025) were -$23,000.
• The value of Property, Plant & Equipment reported on the balance sheet was $0.16 million for 2022, $0.42 million for 2023, and $2.98 million for 2024.