(Reuters) – Soleno Therapeutics said on Wednesday it is aware of the death of a 17 year old male who was on the company’s treatment for patients who experience feelings of intense and persistent hunger, sending its shares down 12%.
Soleno said the treating physician has reported that the death is not related to the treatment Vykat XR.
Vykat treats hyperphagia, the hallmark symptom of the Prader-Willi syndrome, a genetic disorder caused by full or partial deletions on chromosome 15 that affect the regulation of gene expression, or how genes turn on and off.
Soleno said the patient, who also suffered from obesity and other diseases, died from an apparent pulmonary embolus, a blockage in a lung artery usually caused by a blood clot.
Prader-Willi syndrome is a disease where patients have a markedly reduced life expectancy due to several factors, which can include cardiac or respiratory events as well as pulmonary embolism, Soleno said.
The company said the incident has been reported in the U.S. Food and Drug Administration’s public dashboard called the FDA Adverse Event Reporting System.
According to FAERS, 23 adverse events related to Vykat have been reported so far this year. The FDA did not immediately respond to a Reuters request for comment on further action for the treatment.
Last month, Scorpion Capital disclosed a short position in Soleno, citing issues with Vykat. The short seller alleged that the drug causes high risk of fluid buildup in the lungs and heart failure, adding that it “may be at risk of being withdrawn from market.”
(Reporting by Christy Santhosh in Bengaluru; Editing by Alan Barona)
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