Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR
Rhea-AI Summary
Soleno (NASDAQ: SLNO) reported fourth-quarter 2025 product revenue of $91.7M and full-year product revenue of $190.4M from the U.S. launch of VYKAT XR. The company achieved profitability with $20.9M net income for 2025 and ended the year with $506.1M in cash and marketable securities.
Launch metrics through Dec 31, 2025: 1,250 patient start forms, 859 active patients, 630 unique prescribers, and coverage for over 185 million lives. The company invested $100M in an accelerated share repurchase program.
Positive
- Full-year product revenue of $190.4M for 2025
- Fourth-quarter product revenue of $91.7M
- Net income of $20.9M for 2025 (profitability)
- Ending cash and marketable securities of $506.1M
- 1,250 patient start forms received through Dec 31, 2025
- Invested $100M in an accelerated share repurchase program
Negative
- Selling, general and administrative expense increased by $26.2M year-over-year
- Obligation fair-value liability of $20.3M for contingent consideration
- First commercial milestone triggered; $7.0M payable in Q1 2026
- Company expects selling, general and administrative expenses to increase with commercialization
Key Figures
Market Reality Check
Peers on Argus
SLNO was down 1.24% pre-release while close biotech peers were mixed: MLYS up 4.72%, RARE up 0.44%, SRRK up 0.92%, VKTX up 0.29%, IMVT flat. With no peers in the momentum scanner and no same-day peer news, the setup appears stock-specific rather than part of a coordinated sector move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 04 | Q3 2025 earnings | Positive | -2.7% | Reported Q3 revenue $66M, net income $26M, strong cash and launch metrics. |
| Aug 06 | Q2 2025 earnings | Positive | -3.0% | First full quarter of VYKAT XR revenue and strong cash position post-offering. |
| Jul 10 | Prelim Q2 results | Positive | -9.2% | Preliminary Q2 net revenue range for VYKAT XR with solid early launch data. |
| May 07 | Q1 2025 earnings | Positive | +2.1% | Post-approval launch update, EU filing plans, and strong cash resources. |
| Feb 27 | FY 2024 earnings | Positive | +8.5% | Priority review, financing, and commercial build-out ahead of VYKAT XR launch. |
Across the last 5 earnings-related releases, the average next-day move was -0.87%, with more instances of negative reactions to generally constructive updates, indicating a tendency toward cautious or profit-taking responses around earnings.
Recent history shows a steady transition from pre-commercial to commercial execution. The Feb 2025 earnings release highlighted FDA priority review and financing to prepare for launch. Subsequent Q1–Q3 2025 earnings updates detailed the ramp of VYKAT XR with rising product revenue, growing patient start forms, and strong cash balances. Preliminary and scheduling updates in 2025–2026 reinforced this trajectory. Today’s full-year 2025 results confirm profitability and robust launch metrics, extending that commercialization narrative.
Historical Comparison
Over the last 5 earnings/financial updates, SLNO’s average next-day move was -0.87%, showing generally subdued to cautious reactions to fundamentally positive progress.
Earnings events tracked the shift from pre-approval (FY 2024) to Q1–Q3 2025 commercialization of VYKAT XR, with sequential revenue build, expanding prescriber and patient metrics, and strengthening cash, setting the stage for the current first full profitable year.
Market Pulse Summary
This announcement highlights Soleno’s transition to a profitable commercial-stage company, with $190.4M in 2025 revenue, $20.9M in net income, and $506.1M in year-end cash and securities. VYKAT XR adoption metrics—patient start forms, active patients, and prescriber counts—frame the launch trajectory, while changing R&D and SG&A spend show how resources are shifting from development to commercialization and international expansion. Investors may watch future quarters for revenue durability, expense trends, and progress in new indications and geographies.
Key Terms
prader-willi syndrome medical
hyperphagia medical
nda submission regulatory
hbA1c medical
AI-generated analysis. Not financial advice.
REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on the U.S. launch of VYKAT™ XR (diazoxide choline) extended-release tablets.
Fourth Quarter and Full-Year 2025 and Recent Corporate Highlights
- Revenue, net, from the sale of VYKAT XR for the three and twelve months ended December 31, 2025, was
$91.7 million and$190.4 million , respectively. - From approval on March 26, 2025 through December 31, 2025, Soleno reports:
- 1,250 patient start forms received, including 207 in the fourth quarter
- 630 unique prescribers, including 136 new prescribers in the fourth quarter
- 859 active patients on drug as of December 31, 2025
- Over 185 million lives covered
- Achieved profitability with positive net income of
$20.9 million for the year. - Generated
$48.7 million of cash flow from operating activities in the fourth quarter. - Invested
$100 million in accelerated share repurchase program announced in November 2025 and ended the year with$506.1 million of cash, cash equivalents and marketable securities.
“Our first year as a commercial organization has been an outstanding success,” stated Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “In just nine months, we received patient start forms representing over
“Looking ahead, with the U.S. VYKAT XR launch well underway, we plan to pursue regulatory approval in other territories, starting with the EU. We will also begin to evaluate diazoxide choline extended-release (DCCR) in additional high-need rare diseases as we expand our development pipeline. We have made excellent progress in 2025 and are excited for the year ahead.”
Fourth Quarter and Full-Year Ended December 31, 2025 Financial Results
Product revenue, net, was
Research and development expense was
For the year, the
Selling, general and administrative expense was
For the year, personnel costs, including hiring expense and other associated headcount costs, increased
The Company is obligated to make cash payments of up to a maximum of
Total other income, net, was
For the year ended December 31, 2025, net income was approximately
Conference Call and Webcast Information
Soleno management will host an investor conference call and webcast to discuss its fourth quarter and full-year 2025 financial and operating results and provide an update on the U.S. launch of VYKAT XR today, February 25, 2026, at 4:30pm ET. Details can be found below:
| Conference call details: | Toll-free: 800-717-1738 |
| International: 646-307-1865 | |
| Conference ID: 55257 | |
| Call me™ (avoids waiting for an operator): | Here |
| Webcast: | Here |
About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.
INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
IMPORTANT SAFETY INFORMATION
Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.
Warnings and Precautions
Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.
Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.
Adverse Reactions
The most common adverse reactions (incidence ≥
Please see the full Prescribing Information, including Medication Guide.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company's prior press releases and in the periodic reports it files with the SEC including its Annual Report on Form 10-K which it intends to release later today. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
| Soleno Therapeutics, Inc. Consolidated Balance Sheets (In thousands except share and per share data) | |||||||
| December 31, 2025 | December 31, 2024 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 70,106 | $ | 87,928 | |||
| Marketable securities | 235,366 | 203,509 | |||||
| Accounts receivable, net | 28,208 | — | |||||
| Inventory, net | 15,024 | — | |||||
| Prepaid expenses and other current assets | 7,110 | 2,452 | |||||
| Total current assets | 355,814 | 293,889 | |||||
| Long-term assets | |||||||
| Property and equipment, net | 185 | 186 | |||||
| Operating lease right-of-use assets | 2,191 | 2,798 | |||||
| Intangible assets, net | 4,861 | 6,805 | |||||
| Long-term marketable securities | 200,616 | 27,211 | |||||
| Other long-term assets | 163 | 83 | |||||
| Total assets | $ | 563,830 | $ | 330,972 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 12,435 | $ | 8,882 | |||
| Accrued compensation | 9,677 | 4,776 | |||||
| Operating lease liabilities | 726 | 526 | |||||
| Contingent liability for Essentialis purchase price | 20,327 | — | |||||
| Other current liabilities | 18,198 | 4,563 | |||||
| Total current liabilities | 61,363 | 18,747 | |||||
| Long-term liabilities | |||||||
| Contingent liability for Essentialis purchase price | — | 14,791 | |||||
| Long-term debt, net | 49,863 | 49,828 | |||||
| Long-term lease liabilities | 1,964 | 2,472 | |||||
| Other long-term liabilities | 525 | 21 | |||||
| Total liabilities | 113,715 | 85,859 | |||||
| Commitments and contingencies (Note 6) | |||||||
| Stockholders’ equity | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 52 | 46 | |||||
| Additional paid-in-capital | 881,018 | 696,966 | |||||
| Accumulated other comprehensive income | 415 | 361 | |||||
| Accumulated deficit | (431,370 | ) | (452,260 | ) | |||
| Total stockholders’ equity | 450,115 | 245,113 | |||||
| Total liabilities and stockholders’ equity | $ | 563,830 | $ | 330,972 | |||
| Soleno Therapeutics, Inc. Consolidated Statements of Operations and Comprehensive Income (Loss) (In thousands except share and per share data) | |||||||||||||||
| Three Months Ended December 31, | Years Ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Product revenue, net | $ | 91,730 | $ | -- | $ | 190,405 | $ | -- | |||||||
| Operating expenses | |||||||||||||||
| Cost of goods sold | 863 | -- | 2,700 | -- | |||||||||||
| Research and development | 9,558 | 21,486 | 40,627 | 78,568 | |||||||||||
| Selling, general and administrative | 40,878 | 37,303 | 132,128 | 105,861 | |||||||||||
| Change in fair value of contingent consideration | 854 | 327 | 5,536 | 3,242 | |||||||||||
| Total operating expenses | 52,153 | 59,116 | 180,991 | 187,671 | |||||||||||
| Operating income (loss) | 39,577 | (59,116 | ) | 9,414 | (187,671 | ) | |||||||||
| Other income (expense), net | |||||||||||||||
| Interest income, net | 5,130 | 3,365 | 16,952 | 12,052 | |||||||||||
| Interest expense | (1,349 | ) | (231 | ) | (5,476 | ) | (231 | ) | |||||||
| Total other income (expense), net | 3,781 | 3,134 | 11,476 | 11,821 | |||||||||||
| Net income (loss) | $ | 43,358 | $ | (55,982 | ) | $ | 20,890 | $ | (175,850 | ) | |||||
| Other comprehensive income (loss) | |||||||||||||||
| Net unrealized gain (loss) on marketable securities | 68 | (537 | ) | 37 | 361 | ||||||||||
| Foreign currency translation adjustment | (13 | ) | 3 | 17 | -- | ||||||||||
| Total comprehensive income (loss) | $ | 43,413 | $ | (56,516 | ) | $ | 20,944 | $ | (175,489 | ) | |||||
| Net income (loss) | 43,358 | (55,982 | ) | 20,890 | (175,850 | ) | |||||||||
| Less: Undistributed earnings attributable to participating securities | (1 | ) | -- | (415 | ) | -- | |||||||||
| Net income (loss) attributable to common stockholders - basic and diluted | $ | 43,357 | $ | (55,982 | ) | $ | 20,475 | $ | (175,850 | ) | |||||
| Net income (loss) per share - basic | $ | 0.82 | $ | (1.27 | ) | $ | 0.40 | $ | (4.38 | ) | |||||
| Net income (loss) per share - diluted | $ | 0.80 | $ | (1.27 | ) | $ | 0.39 | $ | (4.38 | ) | |||||
| Weighted-average common shares outstanding - basic | 53,175,700 | 43,924,831 | 50,817,586 | 40,175,926 | |||||||||||
| Weighted-average common shares outstanding - diluted | 54,331,407 | 43,924,831 | 52,384,886 | 40,175,926 | |||||||||||
| Soleno Therapeutics, Inc. Stock-based Compensation Expense (In thousands) | |||||||||||
| Three Months Ended December 31, | Years Ended December 31, | ||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||
| Research and development | $ | 2,821 | $ | 10,061 | $ | 11,722 | $ | 33,743 | |||
| Selling, general and administrative | 8,650 | 19,694 | 34,124 | 66,215 | |||||||
| Total | $ | 11,471 | $ | 29,755 | $ | 45,846 | $ | 99,958 | |||
FAQ
How much revenue did Soleno (SLNO) report for full-year 2025 from VYKAT XR?
What launch metrics did Soleno (SLNO) report for VYKAT XR through December 31, 2025?
Did Soleno (SLNO) report profitability in 2025 and what was the net income?
How much cash did Soleno (SLNO) hold at year-end 2025 and what share buyback activity occurred?
Are there any near-term contingent payments or liabilities for Soleno (SLNO)?
What did Soleno (SLNO) say about future expense trends related to commercialization?
