S&P 500 slips, but losses kept in check as Nvidia climbs ahead of results
REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company valued at $3.73 billion, announced today that its Marketing Authorization Application (MAA) for Diazoxide Choline Prolonged-Release Tablets has been validated by the European Medicines Agency (EMA). This application is for the treatment of Prader-Willi syndrome (PWS) in adults and children aged four years and older. According to InvestingPro data, while the company is not currently profitable, analysts expect positive earnings this year.
The validation marks a significant step in Soleno’s efforts to make the treatment available to the PWS community in the European Union. CEO Anish Bhatnagar, M.D., expressed the company’s commitment to working with European regulators to expedite the review process.
PWS is a rare genetic disorder characterized by hyperphagia, an uncontrollable hunger leading to dangerous overeating. Soleno estimates that around 9,500 patients in the UK, France, Germany, Italy, and Spain could benefit from the treatment. The company has already secured Orphan Drug Designation in the EU, which could provide up to 10 years of market exclusivity upon approval. Wall Street analysts maintain a strong bullish outlook on the stock, with price targets ranging from $97 to $145.
The U.S. Food and Drug Administration (FDA) approved the treatment, branded as VYKAT XR, on March 26, 2025. Soleno’s product is the first commercial offering for the treatment of hyperphagia associated with PWS.
The company’s announcement is based on a press release statement and should be considered in the context of the regulatory approval process, which involves comprehensive review and assessment of the treatment’s safety and efficacy. The stock has shown remarkable performance, gaining over 63% year-to-date. For deeper insights into Soleno’s financial health and growth prospects, including 12 additional ProTips, visit InvestingPro.
In other recent news, Soleno Therapeutics reported a larger-than-expected loss for the first quarter of 2025, with earnings per share (EPS) of -$0.95, missing the forecasted -$0.89. The company did not generate any revenue during this period, and its cash position decreased to $290 million from $318.6 million in the previous quarter. Despite these financial challenges, Soleno achieved a significant milestone with the FDA approval of VYKAT XR, a treatment for hyperphagia in Prader-Willi Syndrome, which began patient treatments in April. Cantor Fitzgerald maintained an Overweight rating on Soleno Therapeutics, expressing confidence in the potential of VYKAT XR to boost the company’s revenues. Piper Sandler also reiterated an Overweight rating, highlighting the significant market opportunity for VYKAT XR and the company’s comprehensive commercialization strategy. Oppenheimer analysts maintained an Outperform rating, citing the strong initial commercial performance of VYKAT XR and an increased sales estimate for 2025. Soleno’s management plans to submit an application to the European Medicines Agency for VYKAT XR in the first half of 2025, indicating its commitment to expanding the drug’s availability.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.