01:27 PM EDT, 09/10/2025 (MT Newswires) -- Soleno Therapeutics ( SLNO ) said Wednesday that the US Food and Drug Administration's Adverse Event Reporting System report about a patient death is unrelated to treatment with VYKAT XR, as per the treating physician's assessment.

The company said its assessment is the same, adding that the patient, a 17-year-old male with a history of co-morbidities, died from an apparent pulmonary embolus.

Soleno said Prader Willi Syndrome patients have "significant" co-morbidities and "markedly" reduced life expectancy because of reasons that can include cardiac or respiratory events, and others such as pulmonary embolism.

The company said VYKAT XR has a proven safety and efficacy profile and received approval from the FDA after a "rigorous" clinical program.

Soleno said the existence of a report in the FDA Adverse Event Reporting System database does not mean causation.

The company's shares were down 12% in recent trading.

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