SOLENO THERAPEUTICS (SLNO) Company Report

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.

11 hours ago

Transcript

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.

12 hours ago

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.

Nov 18, 2025, 5:00 PM

Transcript

Solenotherapeutics Highlights Strong VICAT XR Launch and Financial Performance

SLNO

Product Launch

Share Buyback

Revenue Acceleration/Inflection

Solenotherapeutics' drug, VICAT XR, is the first U.S. FDA-approved treatment for hyperphagia in Prader Willi syndrome, a rare disease with a total addressable market (TAM) estimated to be multi-billion dollars.
For the third quarter, the company reported $66 million in net revenue and a positive net income of $26 million, with a strong balance sheet holding approximately $550 million in cash as of September 30.
The company is pursuing geographic expansion with a Marketing Authorization Application (MAA) submitted in Europe, anticipating an approval decision around Q2 of next year.
Solenotherapeutics announced a $100 million accelerated share repurchase program and holds IP protection for VICAT XR into the mid-2030s.

Nov 18, 2025, 5:00 PM

Transcript

Soleno Therapeutics Highlights Strong VYKAT XR Launch, Q3 Profitability, and European Expansion

SLNO

Product Launch

Revenue Acceleration/Inflection

Share Buyback

Soleno Therapeutics has a recently US FDA-approved drug, VYKAT XR, for Prader-Willi syndrome, marking the first drug for this rare disease.
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 a low 8% discontinuation rate for adverse events.
As of September 30, Soleno Therapeutics held $550 million in the bank, reported Q3 net revenue of $66 million, and achieved a positive net income of $26 million, making the company profitable as of the last quarter.
Soleno Therapeutics is pursuing international expansion, having submitted a Marketing Authorization Application (MAA) in Europe in May 2025, with an approval decision likely around Q2 of next year.
The company also announced an accelerated share repurchase program for $100 million a few weeks prior to the conference.

Nov 18, 2025, 5:00 PM

Transcript

Robbins Geller Rudman & Dowd LLP Investigates Soleno Therapeutics, Inc.

SLNO

Legal Proceedings

Demand Weakening

Product Launch

Robbins Geller Rudman & Dowd LLP is investigating Soleno Therapeutics, Inc. (NASDAQ: SLNO) for potential violations of U.S. federal securities laws, focusing on whether the company made false or misleading statements or failed to disclose material information to investors.
The investigation follows Soleno's November 4, 2025, revelation during its quarterly earnings call that the discontinuation rate of its recently FDA-approved drug, VYKAT XR, due to adverse effects was approximately 8% at the end of the third quarter of fiscal 2025.
Soleno's CEO, Anish Bhatnagar, admitted that a short seller report released in mid-August disrupted the VYKAT XR launch trajectory, leading to a lower number of start forms and increased discontinuations for non-serious adverse events.
After this news, the price of Soleno shares fell more than 26%.

Nov 14, 2025, 3:05 PM

Press Release

Soleno Therapeutics Discusses Strong Q3 Performance, Market Penetration, and Stock Buyback

SLNO

Share Buyback

Revenue Acceleration/Inflection

New Projects/Investments

Soleno Therapeutics reported strong Q3 results, including $66 million in revenue (double Q2), profitability, and 397 start forms.
The company has achieved 10% penetration of its 10,000 patient Total Addressable Market (TAM) in six months and projects another 10% penetration within the next 9-12 months.
Management expects continued net patient adds in Q4 and beyond, with current discontinuation rates at 8-10% and long-term projections around 15%.
Payer coverage is robust, with over 130 million lives covered, including payments from 40 Medicaid states and policies from the three largest PBMs.
Soleno Therapeutics executed a stock buyback due to perceived market undervaluation, supported by over $500 million in cash and anticipated continued profitability.

Nov 12, 2025, 1:40 PM

Transcript

Soleno Therapeutics Discusses Strong Q3 Performance, Market Penetration, and EU Outlook

SLNO

Earnings

Product Launch

Share Buyback

Revenue Acceleration/Inflection

Soleno Therapeutics reported an "outstanding" Q3, achieving $66 million in revenues (double Q2), 397 start forms, and profitability.
The company has penetrated 10% of its 10,000-patient Total Addressable Market (TAM) in six months and expects to reach an additional 10% of the TAM in the next 9-12 months, anticipating continued net patient adds.
A stock buyback was executed, driven by the market's perceived undervaluation and the company's strong financial position, including over $500 million in cash and sustained profitability.
Payer coverage is strong, with over 130 million lives covered across commercial, Medicare, and Medicaid, and reauthorizations are proceeding as expected.
For the EU market, an approval decision is projected approximately a year from May 2025, targeting 9,500 diagnosed patients in EU4 plus the UK.

Nov 12, 2025, 1:40 PM

Transcript

Soleno Therapeutics Discusses Strong Q3 Results and Share Buyback

SLNO

Earnings

Share Buyback

Revenue Acceleration/Inflection

Soleno Therapeutics reported Q3 revenues of $66 million, which was double Q2, and stated the company was profitable.
The company executed a stock buyback due to perceived market undervaluation, supported by over $500 million of cash and anticipated continued profitability.
Soleno has achieved 10% of the Total Addressable Market (TAM) of 10,000 patients in six months and expects to reach another 10% of the TAM in the next 9 to 12 months, with continued net patient additions.
The company is progressing with its Marketing Authorization Application (MAA) in the EU, with a projected approval decision approximately a year from May, targeting 9,500 diagnosed patients in the EU4 plus UK.
Discontinuation rates are currently 8%-10%, with an expected long-term adherence rate of about 80%.

Nov 12, 2025, 1:40 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for SOLENO THERAPEUTICS.

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