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REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company with a market capitalization of $3.08 billion, announced today the U.S. commercial availability of VYKAT XR, an FDA-approved medication for hyperphagia in individuals four years and older with Prader-Willi syndrome (PWS). The release of VYKAT XR follows its FDA approval on March 26, 2025, marking it as the sole treatment specifically sanctioned for hyperphagia associated with PWS. The company’s stock has shown remarkable strength, delivering an 81% return over the past year, trading at $67.23.
Hyperphagia, a condition characterized by an insatiable appetite and food-seeking behavior, is a primary cause of mortality among those with PWS. Dr. Anish Bhatnagar, CEO of Soleno Therapeutics, expressed the company’s commitment to addressing the needs of the PWS community with this first-to-market treatment. He noted the significant interest VYKAT XR has garnered since its approval and assured readiness for a successful commercial launch. According to InvestingPro analysis, analysts maintain a strong buy consensus on the stock, with price targets ranging from $81 to $123.
To support patients, caregivers, and healthcare providers, Soleno has established Soleno ONE, a comprehensive program designed to facilitate access to VYKAT XR. Healthcare professionals can initiate prescription processes through a dedicated website.
Prader-Willi syndrome is a rare genetic disorder resulting from an anomaly on chromosome 15, affecting one in every 15,000 live births. The complications of hyperphagia include life-threatening risks such as stomach rupture and choking, and long-term health issues like diabetes and cardiovascular disease.
VYKAT XR is contraindicated for patients with known hypersensitivity to diazoxide or thiazides and comes with warnings about potential hyperglycemia and fluid overload risks. The most common adverse reactions include hypertrichosis, edema, hyperglycemia, and rash.
Soleno Therapeutics focuses on developing and commercializing treatments for rare diseases, with VYKAT XR as its inaugural product. While not currently profitable, InvestingPro data indicates analysts expect the company to achieve profitability this year, with projected earnings per share of $7.31 for 2025. The company’s forward-looking statements suggest a positive outlook for the medication’s role in the PWS community, although these statements are subject to risks and uncertainties. For deeper insights into Soleno’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro, along with 11 additional ProTips and extensive financial metrics.
This news article is based on a press release statement from Soleno Therapeutics.
In other recent news, Soleno Therapeutics Inc. has received FDA approval for its VYKAT XR tablets, a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS). This approval has prompted several analyst firms to adjust their price targets for Soleno. H.C. Wainwright raised its target from $70 to $100, while Stifel increased its target from $74 to $108, both maintaining Buy ratings. Guggenheim also raised its target to $81 from $70, citing the drug’s potential market impact.
Piper Sandler maintained its $93 target, emphasizing the clean label of VYKAT XR, which is expected to facilitate market adoption. The new drug is anticipated to be available in the U.S. market by April 2025, with a weight-based pricing strategy set at approximately $466,200 annually. Analysts forecast significant revenue potential, with Stifel estimating up to $2 billion and Guggenheim projecting $1.6 billion by 2030. These developments highlight the strong market interest and potential financial growth for Soleno Therapeutics following the drug’s approval.
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