Soleno Therapeutics, Inc.
- Open
- 53.01
- Day high
- 53.01
- Day low
- 53.01
- Prev close
- 53.01
- Volume
- 0
- Mkt cap
- $2.8B
- P/E (TTM)
- 27.1
- EPS (TTM)
- $1.96
- P/B
- 5.6
- P/S
- 9.7
- Yield
- —
- Per share
- —
Soleno Therapeutics, Inc. (SLNO) is a Healthcare company listed on NASDAQ. The stock is down 30% over the past year.
Soleno Therapeutics, Inc. (SLNO) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 5 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
SLNO earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| May 7, 2026 | $0.73 | $0.59 | -19.2% | $95M | +0.9% |
| Feb 25, 2026 | $0.64 | $0.80 | +25.0% | $92M | +3.5% |
| Nov 4, 2025 | $0.06 | $0.47 | +717.4% | $66M | -25.4% |
| Feb 27, 2025 | $-0.63 | $-1.27 | -101.6% | — | — |
| May 9, 2024 | $-0.30 | $-0.59 | -96.7% | — | — |
| Mar 6, 2024 | $-0.31 | $-0.33 | -6.5% | $3M | — |
| Mar 21, 2023 | $-0.76 | $-0.58 | +23.7% | — | — |
| Aug 10, 2022 | $-1.05 | $-0.90 | +14.3% | — | — |
| Mar 31, 2022 | $-1.20 | $-1.20 | +0.0% | — | — |
| Nov 10, 2021 | $-1.65 | $-1.50 | +9.1% | — | — |
| Jul 28, 2021 | $-1.20 | $-2.10 | -75.0% | — | — |
| May 5, 2021 | $-0.60 | $-1.65 | -175.0% | — | — |
SLNO insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Mar 31, 2026 | Manning Meredithofficer: Chief Commercial Officer | Sell | 2,100 | $31.04 |
| Mar 31, 2026 | Manning Meredithofficer: Chief Commercial Officer | Sell | 558 | $31.72 |
| Mar 31, 2026 | Huang Michael F.officer: Sr. VP of Clinical Development | Sell | 488 | $31.72 |
| Mar 31, 2026 | Manning Meredithofficer: Chief Commercial Officer | Sell | 4,864 | $30.04 |
| Mar 31, 2026 | Huang Michael F.officer: Sr. VP of Clinical Development | Sell | 1,838 | $31.04 |
| Mar 31, 2026 | Huang Michael F.officer: Sr. VP of Clinical Development | Sell | 4,256 | $30.04 |
| Mar 4, 2026 | Fulk Jenniferofficer: CHIEF FINANCIAL OFFICER | Option | 67,660 | $39.06 |
| Mar 4, 2026 | Fulk Jenniferofficer: CHIEF FINANCIAL OFFICER | Grant | 39,200 | — |
| Jan 23, 2026 | Anish Bhatnagardirector, officer: CHIEF EXECUTIVE OFFICER | Grant | 114,200 | — |
| Jan 23, 2026 | Yen Kristenofficer: SEE REMARKS | Grant | 11,900 | $43.65 |
| Jan 23, 2026 | Huang Michael F.officer: Sr. VP of Clinical Development | Grant | 11,900 | $43.65 |
| Jan 23, 2026 | Joshi Manherofficer: Chief Development Officer | Grant | 4,100 | — |
| Jan 23, 2026 | Norrett Kevinofficer: Chief Business Officer | Grant | 4,000 | $43.65 |
| Jan 23, 2026 | Yen Kristenofficer: SEE REMARKS | Grant | 10,400 | — |
| Jan 23, 2026 | Joshi Manherofficer: Chief Development Officer | Grant | 4,700 | $43.65 |
Source: SLNO SEC Form 4 filings, latest Mar 31, 2026. For informational purposes only — not investment advice.
See the full SLNO insider & 13F page →Soleno Therapeutics, Inc. company profile
Overview
Soleno Therapeutics, Inc. (NASDAQ:SLNO) is a clinical-stage biopharmaceutical company founded in 1999 and headquartered in Redwood City, California. Originally incorporated as Capnia, Inc., the company changed its name to Soleno Therapeutics in May 2017 to reflect its strategic pivot toward developing treatments for rare diseases. After years of clinical development, Soleno achieved a major milestone in 2025 when the FDA approved its lead drug candidate, VYKAT XR, making it the first and only FDA-approved treatment for hyperphagia (excessive hunger) in patients with Prader-Willi Syndrome aged 4 years and older.
Business
Soleno Therapeutics operates in the rare disease pharmaceutical sector, specifically focusing on developing treatments for genetic disorders with significant unmet medical needs. The company's core business revolves around VYKAT XR (Diazoxide Choline Controlled-Release), a once-daily oral tablet that represents a breakthrough treatment for Prader-Willi Syndrome (PWS). Prader-Willi Syndrome is a rare genetic disorder that affects approximately 1 in 15,000 births and is characterized by severe hyperphagia - an insatiable hunger that leads to dangerous overeating and life-threatening obesity. PWS patients experience a dysfunction in their hypothalamus, the brain region that controls hunger and satiety signals, causing them to never feel full regardless of how much they eat. This condition typically manifests in early childhood and requires constant supervision to prevent patients from eating themselves to death. VYKAT XR works by modulating potassium channels in pancreatic cells, which helps regulate insulin secretion and glucose metabolism. By controlling these metabolic pathways, the drug helps reduce the overwhelming hunger drive that characterizes PWS, allowing patients to achieve better weight control and improved quality of life. The medication is formulated as a controlled-release tablet that provides sustained therapeutic effects throughout the day with once-daily dosing. The company operates as a single-segment business focused entirely on PWS treatment, with VYKAT XR representing virtually 100% of its commercial opportunity and pipeline value.
Revenue model
Soleno generates revenue through direct pharmaceutical product sales of VYKAT XR to patients with Prader-Willi Syndrome. The company employs a traditional pharmaceutical business model where it sells its prescription medication through specialty pharmacies and healthcare providers to end patients. The primary paying customers include insurance companies (both private and government programs like Medicaid), patients with out-of-pocket costs, and healthcare systems. The company has identified an addressable market of approximately 10,000 PWS patients in the United States, with an additional 9,500 patients across the European Union and United Kingdom. Given the rare disease status and lack of alternative treatments, VYKAT XR commands premium pricing typical of orphan drugs, though specific pricing details have not been disclosed. Several factors could significantly impact Soleno's profitability margins. Positive factors include the drug's orphan disease designation, which provides market exclusivity and pricing power, limited competition in the PWS treatment space, and the chronic nature of the condition requiring lifelong treatment. The company also benefits from streamlined regulatory pathways for rare diseases and potential insurance coverage given the serious medical need. However, margin pressures could arise from the small patient population limiting overall market size, high costs associated with rare disease commercial infrastructure including specialized sales teams and patient support programs, potential pricing pressure from payers despite the unmet need, and manufacturing costs for a controlled-release formulation. Additionally, the company faces ongoing research and development expenses as it expands internationally and potentially develops the drug for additional indications.
Competitive moat
Soleno Therapeutics possesses a relatively strong competitive moat in the Prader-Willi Syndrome treatment market, primarily driven by regulatory exclusivity and first-mover advantages. The company's most significant moat is its FDA approval for VYKAT XR, which represents the first and only approved treatment specifically for hyperphagia in PWS patients. This regulatory approval creates substantial barriers to entry, as competitors would need to conduct their own extensive clinical trials and navigate the FDA approval process, which typically takes years and costs hundreds of millions of dollars. The orphan drug designation provides additional protection through market exclusivity periods and regulatory incentives. The small, well-defined patient population of approximately 10,000 individuals in the US creates natural barriers to competition, as the limited market size makes it economically challenging for multiple competitors to justify the substantial investment required for drug development and commercialization. However, the moat faces potential threats from several directions. Acadia Pharmaceuticals is developing carbetocin for PWS, and Arbor Pharmaceuticals has another competing product in late-stage development. These companies could potentially offer alternative mechanisms of action or improved efficacy profiles. Additionally, the relatively straightforward mechanism of action (potassium channel modulation) means the drug is not protected by particularly complex or proprietary technology that would be difficult to replicate. The company's moat strength is moderate rather than exceptional, as it relies primarily on regulatory exclusivity and timing rather than proprietary technology, network effects, or switching costs that characterize stronger competitive positions. The durability of the moat will largely depend on the company's ability to establish strong relationships with the PWS treatment community and demonstrate superior clinical outcomes before competitors enter the market.
Risks & safety
Soleno Therapeutics presents a moderate margin of safety profile, with strong liquidity but elevated valuation metrics reflecting its recent commercial launch. **Cash Position and Solvency:** - Strong cash position with $290 million in cash, cash equivalents, and marketable securities as of Q1 2025 - Additional $75 million available through loan agreement tranches - Current quarterly cash burn of approximately $33 million suggests roughly 2-3 years of runway at current spending levels - Excellent current ratio of 19.6x and minimal debt-to-equity ratio of 0.01x indicating very low solvency risk - Management expects cash to fund operations through cash flow breakeven **Valuation Concerns:** - Price-to-book ratio of 14.2x appears elevated for a company just beginning commercial operations - No meaningful revenue yet generated despite FDA approval, making traditional valuation metrics difficult to assess - Enterprise value reflects significant premium for future growth expectations rather than current fundamentals **Other Considerations:** - Binary risk profile typical of single-product biotech companies - success depends almost entirely on VYKAT XR commercial performance - Early commercial traction showing 268 patient start forms in first 29 business days provides some validation - International expansion opportunity in EU/UK could provide additional revenue diversification
Recent development
Over the past few years, Soleno Therapeutics has undergone a dramatic transformation from a clinical-stage company to a commercial-stage pharmaceutical business. The most significant milestone was achieving FDA approval for VYKAT XR in early 2025, culminating years of clinical development including a successful Phase III trial program. This approval marked a historic moment as VYKAT XR became the first FDA-approved treatment specifically for hyperphagia in Prader-Willi Syndrome patients. The company successfully executed its commercial launch in mid-April 2025, with the first patients receiving treatment shortly after approval. Early commercial metrics demonstrate promising uptake, with 268 patient start forms received from 131 unique prescribers within the first 29 business days of launch. The company is targeting both top-tier PWS specialty centers and community practitioners to maximize patient reach. Strategically, Soleno is pursuing international expansion with plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency in the first half of 2025. The company is evaluating whether to commercialize independently in Europe or partner with established pharmaceutical companies, representing a key strategic decision that could significantly impact future growth trajectory. The company has also strengthened its financial position substantially, building cash reserves to $290 million and securing additional funding capacity through loan agreements. This financial foundation provides the runway necessary to execute both domestic commercial operations and international expansion plans while maintaining development activities for potential additional indications or formulations.
SLNO company profile · for informational purposes only — not investment advice.
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