Shares of Soleno Therapeutics, Inc. (“Soleno”) fell over 12% on September 10, 2025, after the company disclosed a patient death involving its treatment for Prader-Willi Syndrome, VYKAT XR. Previously, on Friday, August 15, 2025, Soleno stock dropped more than 8% after Scorpion Capital released a report alleging that VYKAT XR poses serious safety concerns and is potentially at risk of being withdrawn from the market. Gibbs Mura is investigating a potential Soleno Therapeutics, Inc. (NASDAQ: SLNO) Securities Class Action Lawsuit concerning whether Soleno has violated federal securities laws by providing false or misleading statements to investors.

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What is the Soleno Lawsuit Investigation About?

On August 15, 2025, Scorpion Capital released a 415-page report alleging that Soleno’s recently approved treatment for Prader-Willi syndrome, VYKAT XR, poses serious safety concerns and is potentially at risk of being withdrawn from the market. The report cites a “rapid pile-up of reports of children hospitalized for potential heart failure in recent weeks, shortly after starting VYKAT XR.”

Additionally, Scorpion Capital claims that Soleno’s “hocus-pocus” launch metrics obscure the company’s dependence on a controversial Florida physician that has a “pattern of association with questionable [Prader-Willi Syndrome] therapies.”

Finally, Scorpion Capital claims that “Soleno’s clinical trials were a sham that make a mockery of the scientific method,” specifically citing a withdrawal study that “exhibits red flags for suspect data/results,” along with comments from ex-employees and others expressing concern about the company’s alleged trial practices.

Following the report, shares of Soleno fell over 8% on August 15, 2025, causing harm to investors.

Then, on September 10, 2025, Soleno disclosed a patient death involving its Prader-Will Syndrome treatment, VYKAT XR, which was reported in the FDA’s Adverse Event Reporting System. Following this news, shares of Soleno fell over 12% on September 10, 2025, causing further harm to investors.

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