SOLENO THERAPEUTICS (SLNO) Company Report

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.

4 days ago

8-K

Soleno Therapeutics Announces Preliminary Q4 and Full-Year 2025 Results

SLNO

Earnings

Guidance Update

Share Buyback

Soleno Therapeutics announced preliminary unaudited full-year 2025 net revenue from U.S. VYKAT™ XR sales is expected to be in the range of $189 million to $191 million, with fourth quarter 2025 net revenue projected between $90 million and $92 million.
The company achieved profitability and positive cash flow in 2025.
Year-end 2025 cash, cash equivalents, and marketable securities were approximately $500 million, following a $100 million accelerated share repurchase program announced on November 11, 2025.
VYKAT XR recorded 1,250 total new patient start forms from launch through December 31, 2025, representing approximately 12.5% of the total U.S. addressable market.

4 days ago

Press Release

Soleno Therapeutics Faces Investigation Amid Product Safety Concerns and Stock Declines

SLNO

Legal Proceedings

Demand Weakening

Pomerantz LLP is investigating Soleno Therapeutics, Inc. (SLNO) for potential securities fraud or other unlawful business practices.
On August 15, 2025, a Scorpion Capital report described Soleno's only product, Vykat XR, as overpriced and potentially unsafe for children, causing Soleno's stock to fall 7.41% to $71.63 per share.
Soleno disclosed on November 4, 2025, that the discontinuation rate of Vykat XR due to adverse effects was approximately 8% at the end of the third quarter of fiscal 2025, which the CEO attributed to the short seller report impacting its launch trajectory.
Following this news, Soleno's stock price fell 26.59% to close at $46.87 per share on November 5, 2025.

Jan 6, 2026, 5:47 PM

Press Release

Soleno Therapeutics announces publication of VYKAT™ XR study results

SLNO

Product Launch

New Projects/Investments

Soleno Therapeutics announced the publication of results from its 16-week randomized withdrawal study (C602-RWP) of VYKAT™ XR in the Journal of Clinical Endocrinology and Metabolism (JCEM).
The study demonstrated that hyperphagia worsened significantly when VYKAT XR treatment was withdrawn, compared to continued administration, reinforcing its safety and efficacy for Prader-Willi syndrome (PWS) (P=0.0022).
VYKAT™ XR was approved by the U.S. FDA on March 26, 2025, as the first and only treatment for hyperphagia in PWS, and is now commercially available to U.S. patients.

Jan 5, 2026, 1:00 PM

Press Release

Soleno Therapeutics Faces Investigation by Pomerantz LLP

SLNO

Legal Proceedings

Demand Weakening

Pomerantz LLP is investigating Soleno Therapeutics, Inc. (SLNO) for potential securities fraud or other unlawful business practices.
On August 15, 2025, Soleno's stock price fell 7.41% to $71.63 per share after Scorpion Capital published a report describing its product, Vykat XR, as overpriced and potentially unsafe.
During its Q3 fiscal 2025 earnings call on November 4, 2025, Soleno revealed an approximate 8% discontinuation rate for Vykat XR due to adverse effects, with the CEO linking this to the short seller report.
Following this disclosure, Soleno's stock price dropped an additional 26.59% on November 5, 2025, closing at $46.87 per share.

Dec 30, 2025, 9:50 PM

Press Release

Pomerantz LLP Investigates Soleno Therapeutics Following Product Concerns and Stock Decline

SLNO

Legal Proceedings

Demand Weakening

Product Launch

Pomerantz LLP is investigating Soleno Therapeutics, Inc. (SLNO) for potential securities fraud or unlawful business practices on behalf of its investors.
This investigation follows a Scorpion Capital report on August 15, 2025, which alleged that Soleno's only product, Vykat XR, is overpriced and potentially unsafe for children.
Soleno's stock price experienced significant drops, falling 7.41% on August 15, 2025, and an additional 26.59% on November 5, 2025, after the company disclosed an 8% discontinuation rate for Vykat XR related to adverse effects during its Q3 FY2025 earnings call.

Dec 11, 2025, 3:00 PM

Press Release

Soleno Therapeutics Provides Update on ViCAT Launch and Market Outlook

SLNO

Product Launch

Guidance Update

Revenue Acceleration/Inflection

Soleno Therapeutics reports a strong, successful launch of ViCAT, achieving 10% of its target addressable market (TAM), or 1,000 patients, in the first six months. In Q3, there were 1,043 starts and 764 active patients.
While not providing formal revenue guidance, the company notes the current consensus for ViCAT's Q4 2025 revenue is $83.3 million and projects 2026 peak sales of $463 million, with the company believing it will exceed $1 billion in a few years.
Market access for ViCAT is robust, with over 130 million lives covered and payments coming through all channels, including Medicaid in over 40 states and favorable policies from the three largest PBMs.
The company received Day 120 Questions for its European regulatory filing and expects to submit responses within the next few weeks.

Dec 4, 2025, 2:00 PM

Transcript

Soleno Therapeutics Discusses Strong VYKAT XR Launch and Future Sales Projections

SLNO

Product Launch

Guidance Update

Revenue Acceleration/Inflection

Soleno Therapeutics reported a strong launch for VYKAT XR, reaching 10% of its Total Addressable Market (TAM), or approximately 1,000 patients, within the first six months. The company aims to add another 10% in the subsequent 9-12 months.
While not providing specific revenue guidance, Soleno's CFO indicated that VYKAT XR sales are projected to reach north of $1 billion in a few years, exceeding the 2026 consensus of $463 million.
Market access for VYKAT XR is robust, with over 130 million lives covered across Medicaid, Medicare, and commercial channels, and favorable policies from the three largest PBMs.
In Q3, the company reported 1,043 start forms and 764 active patients. Adverse events observed are within the product label (hypertrichosis, fluid retention, hyperglycemia) and consistent with rates seen in clinical trials.
Soleno has received Day 120 Questions for its European regulatory filing and expects to submit the response within the next few weeks.

Dec 4, 2025, 2:00 PM

Transcript

Soleno Therapeutics Provides Update on VYKAT XR Launch, Financials, and European Expansion

SLNO

Product Launch

Share Buyback

New Projects/Investments

Soleno Therapeutics has received US FDA approval for VYKAT XR, the first drug for Prader-Willi syndrome (PWS), targeting a multi-billion dollar market with 12,000-15,000 patients in the U.S. and 400,000 globally.
As of the third quarter, the company reported strong commercial traction for VYKAT XR, with 764 active patients on drug, over 1,000 start forms, and 494 unique prescribers. Reimbursement is robust, covering over $130 million lives.
Soleno Therapeutics is profitable as of the last quarter, reporting $66 million in net revenue and $26 million in positive net income for Q3, with $550 million in cash as of September 30.
International expansion is underway, with a Marketing Authorization Application (MAA) submitted in Europe in May 2025, and an approval decision anticipated around Q2 of next year.
The company also announced a $100 million accelerated share repurchase program a few weeks prior to the document's publication.

Nov 18, 2025, 5:00 PM

Transcript

Soleno Therapeutics Reports Profitability and Strong VYKAT XR Launch

SLNO

Product Launch

Share Buyback

Revenue Acceleration/Inflection

Soleno Therapeutics has received US FDA approval for VYKAT XR, the first drug for Prader-Willi syndrome, targeting a multi-billion dollar market with an estimated 12,000 to 15,000 patients in the US and 400,000 globally.
The company reported strong commercial traction as of the end of the third quarter, with over 1,000 start forms, 494 unique prescribers, and 764 active patients on drug, alongside an 8% discontinuation rate for adverse events.
Financially, as of September 30, Soleno had $550 million in cash, achieved net revenue of $66 million in the third quarter, and a positive net income of $26 million, making it profitable as of the last quarter.
Strategic initiatives include geographic expansion with an MAA submission in Europe (approval decision expected around Q2 next year) and IP protection into the mid-2030s. The company also announced a $100 million accelerated share repurchase program.