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REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ:SLNO), whose stock has surged 116% over the past year and is trading near its 52-week high of $85.36, presented new data on VYKAT XR (diazoxide choline) extended-release tablets for Prader-Willi syndrome (PWS) at the 2025 United in Hope conference, according to a company press release. InvestingPro analysis indicates the stock is currently trading above its Fair Value.
The data showed that patients with strict food controls experienced statistically significant reductions in hyperphagia symptoms when treated with VYKAT XR. Hyperphagia, a persistent hunger leading to aggressive food-seeking behavior, is a primary characteristic of PWS.
Results indicated that patients in highly food-restricted environments showed clinically meaningful reductions in hyperphagia scores that were often numerically greater than those in less restricted groups through Year 3 of treatment.
A separate analysis demonstrated that VYKAT XR can be administered safely to PWS patients with pre-diabetes or diabetes, who comprised 60% of study participants. Efficacy outcomes at Week 156 were similar between patients with and without these conditions.
While hyperglycemia-related adverse events were more common in the pre-diabetes/diabetes group (42.7% versus 24.0%), these events were generally manageable with low discontinuation rates (4.0% versus 6.0%).
VYKAT XR was approved by the FDA on March 26, 2025, for treating hyperphagia in PWS patients aged 4 and older. Common adverse reactions included hypertrichosis, edema, hyperglycemia, and rash.
PWS is a rare genetic neurodevelopmental disorder occurring in approximately one in 15,000 live births, characterized by hyperphagia that can lead to significant health complications including diabetes, obesity, and cardiovascular disease. Analysts maintain a highly bullish outlook on Soleno, with price targets ranging from $97 to $145, reflecting confidence in VYKAT XR’s market potential.
In other recent news, Soleno Therapeutics has been the focus of several analyst reports and regulatory updates. The company announced that its Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets, branded as VYKAT XR, has been validated by the European Medicines Agency. This step is crucial for making the treatment available to the Prader-Willi syndrome community in the European Union. Additionally, the U.S. Food and Drug Administration approved VYKAT XR earlier this year, marking it as the first commercial treatment for hyperphagia associated with Prader-Willi syndrome.
Analyst firms have expressed varying degrees of optimism about Soleno Therapeutics. TD Cowen initiated coverage with a buy rating and a price target of $110, highlighting the drug’s potential to meet unmet medical needs. Piper Sandler reiterated an Overweight rating with a $145 price target, emphasizing the drug’s significance as the first approved treatment for Prader-Willi syndrome. Stifel also maintained a Buy rating, citing a positive market entry and the potential for broad use given the large diagnosed population.
Cantor Fitzgerald reaffirmed its Overweight rating and set a price target of $123, underscoring the treatment’s tolerability and efficacy as key factors for long-term adoption. The company is working to secure reimbursement agreements, which analysts believe could significantly impact revenue. Soleno’s management has expressed confidence in their competitive position and patent portfolio, which may further solidify their market standing.
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