Soleno said that its assessment of the death is the same as the treating physician, who said that the death is not related to the treatment with Vykat XR.
Shares of Soleno Therapeutics (SLNO) tumbled 14% on Wednesday following the news of the death of a patient treated with the company’s Vykat XR drug.
The company stated in a filing with the Securities and Exchange Commission that it is aware of a serious adverse event reported in the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) involving a deceased patient. However, the existence of a report in the data does not establish causation, the company said.
Soleno said that its assessment of the death is the same as the treating physician, who said that the death is not related to the treatment with Vykat XR. The 17-year-old boy had a history of comorbidities, including lymphedema, superficial thrombophlebitis, and obesity, the company said, while adding that he died from an apparent pulmonary embolus.
The company said that Vykat XR has a proven safety and efficacy profile and was approved by the FDA following a rigorous clinical program.
“Going forward, Soleno does not intend to specifically comment on adverse events cases (including deaths) unless directly related to VYKAT XR use and unexpected per the U.S. Prescribing Information,” the company stated, while adding that the patient population treated with Vykat XR has significant comorbidities and a markedly reduced life expectancy.
On Stocktwits, retail sentiment around SLNO stock stayed within ‘bearish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.
A Stocktwits user hinted they are exiting their position.
Another user, however, highlighted that the death was unrelated to the drug.
Soleno received the U.S. Food and Drug Administration’s approval for Vykat XR extended-release tablets for the treatment of hyperphagia in patients four years of age and older with Prader-Willi syndrome in March and subsequently launched it in April. Vykat XR is the company’s first commercial product.
Prader-Willi syndrome is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15, estimated to occur in one in every 15,000 live births. The disorder is defined by hyperphagia, an intense, persistent sensation of hunger, which could be life-threatening.
Last month, Scorpion Capital revealed a short position on the stock, alleging several risks associated with Vykat XR, including high risk of pre-diabetes/diabetes, pulmonary edema, and congestive heart failure. Scorpion Capital also stated that it intends to submit an emergency Citizen Petition shortly, requesting that the FDA urge Soleno to conduct a voluntary recall of Vykat XR from the market.
SLNO stock is up 34% this year and approximately 22% over the past 12 months.
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