SOLENO THERAPEUTICS (SLNO) Company Report

Soleno Therapeutics reported total net revenue of $91.7 million for Q4 2025 and $190.4 million for the full year 2025, achieving profitability with a net income of $20.9 million for the full year. The company also generated $48.7 million in cash from operating activities in Q4 2025 and ended the year with $506.1 million in cash equivalents and marketable securities.
The commercial launch of VYKAT XR demonstrated strong uptake, with 1,250 patient start forms received and 859 people on active treatment as of December 31, 2025, representing approximately 12.5% of the U.S. addressable market.
The company is progressing towards a potential EU approval for DCCR, anticipating a regulatory decision by mid-year 2026 after responding to Day 120 questions and expecting Day 180 questions around the end of February 2026.
CFO Jim Mackaness will retire at the end of March 2026, with Jennifer Volk appointed as his successor. The company also invested $100 million in an accelerated share repurchase program announced in November.

2 days ago

Transcript

Soleno Therapeutics Reports Strong Q4 and Full-Year 2025 Results, Announces CFO Retirement, and Outlines Expansion Plans

SLNO

Earnings

Product Launch

CFO Change

Soleno Therapeutics reported Q4 2025 net revenue of $91.7 million and full-year 2025 net revenue of $190.4 million, achieving profitability with a net income of $20.9 million for the full year.
The company ended 2025 with $506.1 million in cash equivalents and marketable securities and generated $48.7 million in cash from operating activities in Q4.
As of December 31, 2025, the VYKAT XR commercial launch saw 1,250 patient start forms received and 859 people on active treatment, representing 12.5% of the U.S. addressable market.
Soleno plans to expand beyond Prader-Willi syndrome, with an IND filing for Glycogen Storage Disease Type I (GSD I) in the first half of 2026 and clinical program initiation later in 2026.
CFO Jim Mackaness announced his retirement effective at the end of March 2026, with Jennifer Volk appointed as his successor.

2 days ago

Transcript

Soleno Therapeutics Reports Strong Q4 and Full Year 2025 Financial and Operational Results

SLNO

Earnings

Product Launch

New Projects/Investments

Soleno Therapeutics reported $91.7 million in net revenue for Q4 2025 and $190.4 million for the full year 2025, achieving a positive net income of $20.9 million for the year. The company generated $48.7 million in cash from operating activities in Q4 and ended the year with $506.1 million in cash equivalents and marketable securities.
Since its commercial launch, VYKAT XR has received 1,250 patient start forms through December 31, 2025, representing approximately 12.5% of the U.S. addressable market, with 859 patients on active treatment. The cumulative launch-to-date discontinuation rate related to adverse events was approximately 12%.
The company anticipates capturing an additional approximately 1,000 patient start forms over the next 9-12 months. Soleno expects to receive Day 180 questions from the EMA around the end of February for DCCR's Marketing Authorisation Application, with a decision anticipated mid-year 2026.
Soleno plans to file an IND in the first half of 2026 for Glycogen Storage Disease Type I (GSD I) and initiate a clinical program later in 2026. VYKAT XR has patents listed in the Orange Book extending to 2035, with potential for further extension into the late 2030s.

2 days ago

Transcript

Soleno Therapeutics Reports Q4 and Full-Year 2025 Financial Results and VYKAT XR Launch Update

SLNO

Earnings

Product Launch

Share Buyback

Soleno Therapeutics reported net product revenue of $91.7 million for the fourth quarter ended December 31, 2025, and $190.4 million for the full-year ended December 31, 2025, from the sale of VYKAT XR. The company achieved profitability with a net income of $20.9 million for the year ended December 31, 2025.
Since the approval of VYKAT XR on March 26, 2025, through December 31, 2025, Soleno Therapeutics received 1,250 patient start forms, had 859 active patients on drug, and engaged 630 unique prescribers.
The company generated $48.7 million of cash flow from operating activities in the fourth quarter of 2025 and ended the year with $506.1 million of cash, cash equivalents, and marketable securities after investing $100 million in an accelerated share repurchase program announced in November 2025.

2 days ago

8-K

Soleno Therapeutics Reports Strong Q4 and Full-Year 2025 Financial Results, Achieves Profitability with VYKAT™ XR Launch

SLNO

Earnings

Product Launch

Share Buyback

Soleno Therapeutics reported net revenue of $91.7 million for the fourth quarter of 2025 and $190.4 million for the full-year 2025 from the sale of VYKAT™ XR.
The company achieved profitability with a net income of $20.9 million for the full-year 2025, or $0.39 per diluted share, a significant improvement from a net loss of $(175.9) million in 2024.
The U.S. launch of VYKAT™ XR saw 1,250 patient start forms received and 859 active patients on drug as of December 31, 2025.
Soleno ended 2025 with $506.1 million in cash, cash equivalents, and marketable securities after investing $100 million in an accelerated share repurchase program.

2 days ago

Press Release

Soleno Therapeutics Discusses Commercial Progress and Future Outlook at Biotech Summit

SLNO

Guidance Update

Product Launch

New Projects/Investments

Soleno Therapeutics, a commercial-stage rare disease company, anticipates reaching approximately 10% of the Total Addressable Market (TAM), equating to 1,000 Start Forms, over the next 9-12 months for its Prader-Willi syndrome product.
The company plans to transition from reporting Start Forms to traditional metrics such as revenue and active patients after the first quarter of 2026, but is not planning to provide full-year guidance for 2026 at this time.
The current Wholesale Acquisition Cost (WAC) is in the $500,000s and is projected to increase to $600,000-$700,000 over the next 2-4 years.
Soleno is building its own team in Europe to pursue a commercial opportunity of approximately 9,500 patients in EU4 plus the UK.

Feb 12, 2026, 4:30 PM

Transcript

Soleno Therapeutics Provides Commercial Update at Biotech Summit

SLNO

Guidance Update

Product Launch

New Projects/Investments

Soleno Therapeutics is a commercial-stage company with a product for Prader-Willi syndrome that has been on the market for about 3 quarters.
The company anticipates achieving approximately 10% of the Total Addressable Market (TAM), equating to 1,000 start forms, over the next 9 to 12 months.
The current Wholesale Acquisition Cost (WAC) is in the $500,000s, with an expectation for a gentle drift up to the $500,000-$700,000 range over the next 2-4 years.
Soleno is not planning to provide full-year guidance at this time, but expects to transition from reporting start forms to revenue and active patients after the first quarter numbers.
The company, which is profitable, sees a significant ex-U.S. opportunity with approximately 9,500 patients in EU4 plus the UK, and is building its own team for a potential launch.

Feb 12, 2026, 4:30 PM

Transcript

Soleno Therapeutics Provides Commercial Launch Update and 2026 Outlook

SLNO

Product Launch

Guidance Update

New Projects/Investments

Soleno Therapeutics, a commercial-stage company with a product for Prader-Willi syndrome, anticipates achieving approximately 10% of the Total Addressable Market (TAM), or 1,000 Start Forms, over the next 9-12 months, with plans to transition reporting to revenue and active patient metrics after the first quarter numbers.
The company is not planning to provide full-year guidance for 2026 at this time, citing the need for further business maturation.
The current Wholesale Acquisition Cost (WAC) is in the $500,000s and is projected to "gently drift up" to between $500,000 and $700,000 over the next 2-4 years.
Reimbursement for the drug has been better than anticipated, with coverage through nearly 48 Medicaids and the removal of new-to-market blocks by all large Pharmacy Benefit Managers (PBMs).
Soleno is actively pursuing the European commercial opportunity, which includes approximately 9,500 patients in the EU4 plus the UK, and is building its own team to potentially self-launch in the region.

Feb 12, 2026, 4:30 PM

Transcript

Soleno Therapeutics (SLNO) Shares Decline Amid Disappointing VYKAT XR Launch and Investor Scrutiny

SLNO

Demand Weakening

Legal Proceedings

Product Launch

On November 5, 2025, Soleno Therapeutics, Inc. (SLNO) shares tumbled $18.78 (-28%) after the company reported disappointing information regarding the launch of its drug, VYKAT™ XR.
During its November 4, 2025 Q3 2025 earnings call, Soleno revealed a disruption in VYKAT™ XR's launch trajectory, characterized by a lower number of new prescriptions and increased discontinuations for non-serious adverse events, contradicting earlier positive assurances from September 2025.
Short seller Scorpion Capital had previously raised concerns on August 15, 2025, about VYKAT™ XR's safety, potential market withdrawal, and alleged irregularities in Soleno's trial data and launch metrics, noting the company's reliance on this single drug whose core patent expires in 2026.
Hagens Berman is investigating Soleno for potentially misleading investors about the commercial prospects of VYKAT™ XR, as the stock price fell nearly 40% between August 14, 2025, and November 5, 2025.

Jan 16, 2026, 5:36 PM

Press Release

Soleno Therapeutics Announces Preliminary Q4 and Full-Year 2025 Results

SLNO

Earnings

Share Buyback

Product Launch

Soleno Therapeutics, Inc. announced preliminary unaudited full-year 2025 net revenue for U.S. sales of VYKAT XR is expected to be in a range of $189 million to $191 million, with fourth quarter 2025 net revenue projected between $90 million and $92 million.
The company has achieved profitability and positive cash flow.
Year-end 2025 cash, cash equivalents, and marketable securities were approximately $500 million, after a $100 million accelerated share repurchase program.
Since its Q2 2025 launch, VYKAT XR has accumulated 1,250 total new patient start forms and 630 unique prescribers, covering over 185 million lives.