Executives from Soleno Therapeutics (NASDAQ:SLNO) provided an update on the company’s commercial launch in Prader-Willi syndrome (PWS), reimbursement dynamics, and regulatory progress in Europe during Guggenheim’s 2026 Emerging Outlook Biotech Summit.
Commercial launch focus remains on patient growth, with start-form reporting set to wind down
Soleno said it is a commercial-stage rare disease company with an approved product for PWS, a genetic disorder where a central feature is hyperphagia, described as an insatiable desire to eat. Management characterized the product as the first approved treatment for the disease and said the drug has been on the market for “about 3/4” (approximately three quarters).
Soleno indicated it is not currently planning to provide full-year guidance, citing the need for the business to mature further and for the company to better understand “ebbs and flows” in launch dynamics, though management said guidance remains “on the table” once it is comfortable.
How start forms translate into revenue and active patients
CFO Jim Mackaness outlined the company’s process for converting start forms into treated and revenue-generating patients. Start forms are submitted by prescribers and processed through the company’s specialty pharmacy partner, Panther, which checks completeness and performs payment assessment. Mackaness said the process can take roughly 30 to 45 days and that a single-digit percentage may be canceled before reaching the active patient base, citing reasons such as administrative errors or family timing issues.
Once drug is shipped, the patient enters the active base. Mackaness said some discontinuation is expected, pointing to long-term clinical evidence suggesting overall discontinuation in the 15% to 20% range. He described that range as healthy in a rare disease setting with comorbidities. He also noted that active patients may be in a “paid” or “free” bucket due to socioeconomic support, quick-start programs, or bridging during coverage transitions. Revenue, he said, is driven by active paid patients, adherence, wholesale acquisition cost (WAC), and gross-to-net.
Seasonality expected in gross-to-net dynamics, not necessarily in start forms
Management said it does not expect the holiday-related variability seen in the fourth quarter to be present in the first quarter, given the absence of major holidays. However, executives emphasized that revenue can experience first-quarter seasonality due to higher gross-to-net discounts. Mackaness explained that insurance copay resets can increase patient out-of-pocket costs, which can raise the company’s copay assistance spending and therefore increase gross-to-net. In addition, coverage disruptions when patients switch plans can temporarily move patients from paid to free drug through bridging programs, also affecting gross-to-net.
The company did not comment on whether revenue would decline sequentially, emphasizing instead that the key metric is continued active patient growth.
Real-world safety and dosing trends generally align with clinical experience
Executives discussed adverse events observed in the real-world setting for VYKAT XR, stating that the types of adverse events appear consistent with the label and clinical trial experience. Bhatnagar listed events including fluid retention, hyperglycemia, rash, and hypertrichosis, and said reported events are predominantly non-serious. He cautioned that raw counts may appear higher because the company has treated “almost 10 times as many patients” commercially as in clinical trials, but said the percentage trends appear similar.
On discontinuations, management clarified that a previously cited roughly 12% discontinuation rate in the fourth quarter was adverse event-related, while overall discontinuation was approximately 15%. Bhatnagar added that, based on both trials and early commercial experience, adverse event-related discontinuations tend to occur earlier in treatment, suggesting that patients who remain on therapy beyond an initial period may be more likely to persist, while noting that data are not yet mature enough for firm predictions.
Regarding titration, Bhatnagar said the company believes the vast majority of patients are reaching their prescribed dose, with a minority titrating differently due to comorbidities or severe obesity. He said the label’s six-week titration framework broadly matches expectations, while acknowledging limited visibility into individual commercial patient management compared with clinical trials. He also said diuretic use appears to be in a minority of patients, based on the information available.
Reimbursement, prescriber expansion, and European regulatory timing
On market access, Bhatnagar said that “lives covered” figures may not be the best representation of progress, adding that Soleno is seeing payments through “almost 48 Medicaids” and described Medicare as one of its best payers. He also said new-to-market blocks on large pharmacy benefit managers have been removed and that policies are being written largely to label. Overall, management described reimbursement as better than expected and said its experienced reimbursement team had “not seen a launch like this before,” while acknowledging there may be one-off prior authorization issues.
The company also highlighted a larger-than-anticipated prescriber base, stating it now has more than 600 prescribers. Bhatnagar said many prescribers have only one or two patients and may lack deep familiarity with PWS and the drug, making education an important component of the launch. He described physician support sessions that can last 30 to 45 minutes and focus on single-patient discussions, which he said have made a difference in some cases.
Internationally, Soleno discussed its European regulatory review process. Bhatnagar described the European Medicines Agency structure, including broad Day 120 questions followed by a narrower Day 180 set, and said the Day 180 questions were expected at the end of February. On the commercial opportunity, he said the patient population in the EU4 plus the UK is about 9,500, and noted that some countries, such as France, route patients through designated centers of excellence. The company said it has begun building its own European team and is increasingly comfortable with the possibility of addressing the market directly, while acknowledging interest from potential partners.
Finally, Bhatnagar said capital deployment priorities include continuing to support the U.S. and ex-U.S. launches, pursuing additional indications for VYKAT, and evaluating inorganic growth opportunities, though he suggested such deals are “probably not in the short term.”
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.
