The score is driven primarily by the sharp 2025 financial inflection (revenue scale, profitability, and improved cash flow) and a very low-debt balance sheet, supported by upbeat earnings-call launch KPIs. Offsetting factors are a high valuation (P/E ~117.9) and technicals showing stretched momentum with the stock still below its 200-day moving average.
Positive Factors
Balance sheet strength
Soleno finished 2025 with a very strong capital position and ample liquidity (cash, cash equivalents and marketable securities of ~$506.1M noted on the call). Low debt and a large asset base materially reduce refinancing and solvency risk, enabling sustained investment in U.S. commercialization, EU activities, and early pipeline programs without near-term financing pressure.
Negative Factors
EU regulatory setback
Withdrawing the EU MAA halts a near-term international expansion path and removes a regulatory catalyst. That delays geographic diversification of revenue, compresses optionality for offshore growth and could force reallocation of resources back to the U.S. launch or rework of the regulatory strategy before re‑filing, extending timelines and execution risk.
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Positive Factors
Negative Factors
Balance sheet strength
Soleno finished 2025 with a very strong capital position and ample liquidity (cash, cash equivalents and marketable securities of ~$506.1M noted on the call). Low debt and a large asset base materially reduce refinancing and solvency risk, enabling sustained investment in U.S. commercialization, EU activities, and early pipeline programs without near-term financing pressure.
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Soleno Therapeutics (SLNO) vs. SPDR S&P 500 ETF (SPY)
Soleno Therapeutics Business Overview & Revenue Model
Company Description
Soleno Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of novel therapeutics for the treatment of rare diseases. Its lead candidate is Diazoxide Choline Controlled-Release, a once-da...
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How the Company Makes Money
Soleno primarily makes money by selling its prescription pharmaceutical product, VYKAT XR (diazoxide choline) extended‑release tablets, in the United States. Revenue is generated through product sales to customers in the pharmaceutical distributio...
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Soleno Therapeutics Earnings Call Summary
Earnings Call Date:Feb 25, 2026
(Q4-2025)
|
% Change Since: |
Next Earnings Date:May 12, 2026
Earnings Call Sentiment Positive
The call communicated a strong commercial launch and material financial progress — meaningful sequential revenue growth (~40% Q/Q), positive operating cash flow and full-year profitability — alongside encouraging commercial metrics (1,250 start forms, 859 active patients, 630 prescribers and coverage of >180M lives). Key near-term risks flagged include EU regulatory uncertainty, anticipated increases in COGS as inventory normalizes, seasonality-driven Q1 gross-to-net effects, elevated SG&A for continued launch investment, and an expected long-term discontinuation range of 15%–20%. On balance, the positive financial and commercial momentum and ample cash runway outweigh the outlined challenges.
Positive Updates
Strong Revenue Growth and Profitability
Q4 net revenue of $91.7M, representing sequential growth of nearly 40% from $66.0M in Q3; full-year 2025 net revenue of $190.4M (note: <9 months of commercial sales). Achieved profitability with full-year net income of $20.9M and Q4 net income of ~$43.4M compared to a net loss in the prior-year periods.
Negative Updates
EU Regulatory Uncertainty
EMA questions focus on adequacy of efficacy data derived primarily from a randomized withdrawal study; Day 180 questions imminent and decision uncertain — EU approval remains unresolved and could impact near-term international expansion plans.
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Q4-2025 Updates
Positive
Negative
Strong Revenue Growth and Profitability
Q4 net revenue of $91.7M, representing sequential growth of nearly 40% from $66.0M in Q3; full-year 2025 net revenue of $190.4M (note: <9 months of commercial sales). Achieved profitability with full-year net income of $20.9M and Q4 net income of ~$43.4M compared to a net loss in the prior-year periods.
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Company Guidance
Management guided to a strong ongoing launch: Q4 net revenue was $91.7M (nearly 40% sequential growth from $66M), full‑year revenue $190.4M (from <9 months of sales), Q4 cash from operations $48.7M, full‑year net income $20.9M, and year‑end cash, cash equivalents and marketable securities of $506.1M (after a $100M accelerated share repurchase). Commercial KPIs through 12/31 included 1,250 patient start forms (~12.5% of the U.S. addressable market), 859 active patients (up from 764 in Q3), 630 unique prescribers (136 added in Q4), coverage for >180 million lives and reimbursed claims from ~45 state Medicaid programs; they expect to capture ~1,000 additional start forms over the next 9–12 months. Safety and retention guidance: launch‑to‑date AE‑related discontinuation ≈12%, total discontinuation ≈15%, and an anticipated long‑term discontinuation rate of 15–20%. Financial and operational notes: Q4 COGS $0.9M (FY $2.7M) with COGS% expected to rise as zero‑cost inventory depletes; Q4 R&D $9.6M (FY $40.6M), Q4 SG&A $40.9M (FY $132.1M); Net income per share Q4 ~$0.82 basic/$0.80 diluted and FY $0.40 basic/$0.39 diluted. Regulatory and pipeline milestones: EMA Day‑180 questions expected end of Feb with a mid‑2026 EU decision window (UK/EU PWS population ~9,500), six Orange Book patents listed (four longest to 2035 with potential extension into the late‑2030s), and GSD‑1 plans (prevalence ~1/100,000 → >7,000 globally, 3–4k in U.S.), with an IND planned in H1 2026 and a clinical program to start later in 2026; the company will share 12‑month KPI updates on the Q1 2026 call and intends to retire those metrics then.
Soleno Therapeutics Financial Statement Overview
Summary
2025 marked a major step-change with $190.4M revenue, profitability (net income $20.9M), and positive operating/free cash flow (~$46.8M/~$46.7M). Balance sheet is a key strength with minimal debt (~$2.7M) versus ~$450.1M equity and substantial liquidity, but durability risk remains given the long history of losses and cash burn prior to 2025.
Income Statement
70
Positive
Balance Sheet
86
Very Positive
Cash Flow
64
Positive
Breakdown
Dec 2025
Dec 2024
Dec 2023
Dec 2022
Mar 2022
Income Statement
Total Revenue
190.41M
0.00
0.00
0.00
0.00
Gross Profit
187.71M
0.00
-1.96M
0.00
0.00
EBITDA
28.38M
-173.63M
-37.03M
-22.10M
-30.30M
Net Income
20.89M
-175.85M
-38.99M
-24.07M
-30.91M
Balance Sheet
Total Assets
563.83M
330.97M
180.69M
26.50M
35.55M
Cash, Cash Equivalents and Short-Term Investments
305.47M
291.44M
169.68M
14.60M
21.30M
Total Debt
2.69M
52.83M
403.00K
155.00K
457.00K
Total Liabilities
113.72M
85.86M
23.18M
16.15M
17.76M
Stockholders Equity
450.12M
245.11M
157.51M
10.35M
17.79M
Cash Flow
Free Cash Flow
46.73M
-69.31M
-24.94M
-20.79M
-27.79M
Operating Cash Flow
46.80M
-69.10M
-24.94M
-20.78M
-27.77M
Investing Cash Flow
-201.78M
-225.68M
0.00
-13.00K
-22.00K
Financing Cash Flow
137.16M
213.03M
180.02M
14.09M
-128.00K
Soleno Therapeutics Technical Analysis
Technical Analysis Sentiment
Positive
Last Price52.64
Price Trends
50DMA
39.20
Positive
100DMA
42.96
Positive
200DMA
56.44
Negative
Market Momentum
MACD
4.12
Negative
RSI
77.93
Negative
STOCH
99.58
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SLNO, the sentiment is Positive. The current price of 52.64 is above the 20-day moving average (MA) of 38.94, above the 50-day MA of 39.20, and below the 200-day MA of 56.44, indicating a neutral trend. The MACD of 4.12 indicates Negative momentum. The RSI at 77.93 is Negative, neither overbought nor oversold. The STOCH value of 99.58 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for SLNO.
Soleno Therapeutics Risk Analysis
Soleno Therapeutics disclosed 63 risk factors in its most recent earnings report. Soleno Therapeutics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Business Operations and StrategyRegulatory Filings and Compliance
Soleno Withdraws EU Application for Prader-Willi Treatment
Negative
Apr 7, 2026
On April 7, 2026, Soleno Therapeutics, Inc. announced that it had voluntarily withdrawn its marketing authorization application in Europe for VIOKAT prolonged-release tablets, known in the U.S. as VYKAT XR, for treating hyperphagia in adults and c...
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Business Operations and StrategyM&A Transactions
Soleno Therapeutics to Be Acquired by Neurocrine Biosciences
Positive
Apr 6, 2026
On April 5, 2026, Soleno Therapeutics agreed to be acquired by Neurocrine Biosciences, which will launch a cash tender offer at $53.00 per share, valuing Soleno’s equity at about $2.9 billion and representing a premium of roughly 34% to Sole...
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Business Operations and StrategyRegulatory Filings and Compliance
On March 16, 2026, Soleno Therapeutics’ Board of Directors approved amended and restated bylaws, acting on recommendations from its Nominating and Corporate Governance Committee. The changes update advance notice requirements for shareholder...
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Business Operations and StrategyExecutive/Board Changes
Soleno Therapeutics Announces New Chief Financial Officer Appointment
Positive
Feb 26, 2026
On its February 25, 2026 earnings call, Soleno announced that veteran pharmaceutical finance executive Jennifer Fulk will become chief financial officer on March 2, 2026, succeeding long-time CFO James Mackaness, who plans to retire by the end of ...
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Business Operations and StrategyExecutive/Board Changes
Soleno Therapeutics Updates Executive Compensation and Severance Plans
Positive
Jan 23, 2026
On January 21, 2026, Soleno Therapeutics’ board, following a review by its independent compensation consultant and Compensation Committee, approved higher base salaries for fiscal 2026, cash bonuses for fiscal 2025, and new stock option and ...
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Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Apr 08, 2026