Soleno Therapeutics (NASDAQ:SLNO) reported fourth-quarter and full-year 2025 financial and operating results highlighting strong commercial performance for VYKAT XR, the company’s treatment for hyperphagia in Prader-Willi syndrome (PWS). Management said the launch, which began in the second quarter of 2025, produced rapid revenue growth, profitability for the year, and expanding uptake among patients and prescribers.
VYKAT XR revenue growth and profitability
Chief Executive Officer Anish Bhatnagar said the company finished 2025 “on a very strong note” and reiterated figures previously pre-announced. Total net revenue for the fourth quarter was $91.7 million, bringing full-year net revenue to $190.4 million, reflecting less than nine months of sales following the product’s commercial launch.
On expenses, Soleno reported cost of goods sold of $0.9 million for the quarter and $2.7 million for the year. Mackaness said cost of goods sold as a percent of revenue is expected to increase as the company depletes inventory produced prior to FDA approval that had been expensed through R&D. He added COGS should “gently nudge up” but remain in the mid-single digits.
Research and development expense was $9.6 million in the fourth quarter and $40.6 million for the year, compared with $21.5 million and $78.6 million, respectively, in 2024. Selling, general, and administrative expense was $40.9 million in the fourth quarter and $132.1 million for the year, compared with $37.3 million and $105.9 million in 2024, with management attributing the increase (excluding stock-based compensation) to ongoing investments to support the launch and broader business activities.
Launch metrics: start forms, active patients, prescribers, and discontinuations
Management pointed to continued growth in early demand indicators. Since launch through December 31, 2025, Soleno received 1,250 patient start forms, which it said represents about 12.5% of the U.S. addressable market for VYKAT XR. As of year-end, 859 people were on active treatment, up from 764 at the end of the third quarter. In the fourth quarter alone, the company reported 207 new patient start forms.
Chief Commercial Officer Meredith Manning said prescriber engagement also expanded, with 136 new prescribers added in the fourth quarter, bringing total unique prescribers to 630 as of December 31. Manning said the company’s field teams are focused on physician education and support, including setting expectations, monitoring, and dose modification.
Regarding the difference between start forms and active patients, management emphasized timing. Bhatnagar said the benefits assessment process can take “30-ish days,” meaning patients do not begin therapy immediately after a start form is received.
On safety and persistence, Bhatnagar said the real-world safety profile continues to mirror expectations and the clinical long-term safety profile. Soleno reported a cumulative launch-to-date discontinuation rate related to adverse events of approximately 12% as of the end of the fourth quarter, with a total discontinuation rate of about 15%. Management reiterated its expectation for a long-term discontinuation rate of 15% to 20%. In response to questions about efficacy-related drop-offs, Bhatnagar said discontinuations for lack of efficacy have been “few at this time,” adding that patients who remain on therapy are seeing benefits, with anecdotes largely centered on hyperphagia and downstream effects such as anxiety and food-related behaviors.
2026 priorities, payer coverage, and seasonality considerations
Looking ahead, Bhatnagar said Soleno believes it can sustain momentum and capture approximately 1,000 additional start forms over the next nine to 12 months, though management cautioned against interpreting that goal on a strict quarter-to-quarter basis.
Manning said 2026 priorities include deepening adoption at leading academic and endocrine centers and further broadening prescribing in community settings. She also highlighted caregiver-focused outreach, including webinars and live events. The company’s January patient webinar attracted over 200 registrants, which management said was nearly 60 more than a November event.
On access, Manning said Soleno had policies covering over 180 million lives at the end of the fourth quarter across commercial, Medicaid, and Medicare channels, and reported strong coverage or reimbursed claims from approximately 45 state Medicaid programs. She added that reauthorizations have generally been processed quickly, with the “overwhelming majority” continued on paid product.
Mackaness also addressed potential first-quarter seasonality effects on reported revenue, noting that annual commercial plan resets can increase gross-to-net discounts due to copay support offered through the company’s Soleno One program and potential temporary shifts of patients into a free-drug bucket during insurance plan changes. He said these dynamics may affect revenue without changing underlying active patient growth.
Regulatory update: EU filing and commercialization planning
Bhatnagar provided an update on efforts to seek approval for DCCR in the European Union. He said Soleno submitted its marketing authorization application in May and subsequently received Day 120 questions, with responses submitted before year-end. Management expects Day 180 questions “around the end of February” and continues to anticipate a decision in the mid-year 2026 timeframe.
Management said key EMA questions have centered on the adequacy of the efficacy dataset, particularly the randomized controlled study design and potential bias considerations. Bhatnagar said these were similar to questions raised by the FDA and that the company will attempt to address them in the EU process.
On commercialization, Soleno said it is considering multiple options, including building its own capabilities in Europe. Bhatnagar estimated about 9,500 people living with PWS in the U.K. and EU4 and described the European market as more concentrated around centers of excellence, with strong thought-leader support for VYKAT XR. Manning said the company is evaluating field force needs and noted it is focusing on potential initial launches in Germany and Austria.
Pipeline expansion: GSD I and other potential indications
Beyond PWS, Bhatnagar said Soleno is pursuing additional metabolic rare disease indications where the mechanism of action applies, starting with Glycogen Storage Disease Type I (GSD I). He described GSD I as a rare metabolic condition with no FDA-approved therapies, estimating global prevalence above 7,000 patients and approximately 3,000 to 4,000 in the U.S. Soleno said DCCR has orphan designation for GSD I in both the U.S. and EU.
Soleno plans to file an IND in the first half of the year and initiate a clinical program later in 2026. On dosing, Bhatnagar said the initial trial will help determine dosing, with management expecting it could be in a similar range to current use due to insulin sensitivity to diazoxide, while noting GSD I patients may not share the same comorbidities seen in PWS.
In response to analyst questions, Bhatnagar also said Soleno continues to evaluate other potential indications where hyperphagia and food-related behaviors are issues, including Smith-Magenis syndrome, aspects of Fragile X, Angelman syndrome, and SIM1 obesity, among others.
Separately, Bhatnagar addressed intellectual property, noting the company has listed patents in the Orange Book, including a method-of-use patent extending to 2035, and said related patents could potentially extend into the late 2030s. He also said Soleno has filed additional IP but did not provide details.
Finally, Mackaness announced he will retire at the end of March, with Jennifer Volk set to take over as CFO in the coming weeks, while he transitions to a consulting role to support the handoff.
About Soleno Therapeutics (NASDAQ:SLNO)
Soleno Therapeutics, Inc is a clinical?stage biopharmaceutical company focused on the development and commercialization of therapies for rare and orphan diseases. Headquartered in Redwood City, California, Soleno leverages a precision medicine approach to identify and advance small?molecule treatments that address underlying genetic and metabolic dysfunctions. The company’s scientific strategy centers on repurposing and reformulating existing compounds to maximize therapeutic benefit in underserved patient populations.
The company’s lead candidate, diazoxide choline controlled release (DCCR), is being investigated for the treatment of Prader-Willi syndrome (PWS), a complex neurodevelopmental disorder characterized by insatiable appetite, hormonal imbalances and behavioral challenges.
-limited-logo-1200x675.png?v=20251024111452&h=45&w=95&zc=2){kind=logo}
