By Angel Adegbesan | Bloomberg
Soleno Therapeutics jumped on Thursday after the drugmaker won US approval for its drug to treat insatiable hunger caused by a genetic disorder.
Shares of the Redwood City, California-based company climbed 38% — the biggest one-day gain since September 2023 — to their highest level in more than eight years.
The Food and Drug Administration approved Soleno’s pill to treat hyperphagia — a condition where individuals have a sense of being hungry all the time and never feeling satisfied — in adults and children four years or older. The condition is a feature of a genetic disorder called Prader-Willi syndrome — which has no cure and affects one in every 10,000 to 30,000 children, according to the National Institutes of Health.
Called Vykat XR, the drug is the first treatment to notch regulatory approval to address the extreme hunger that is associated with Prader-Willi. The regulatory win also marks a milestone for Soleno, as it is the company’s first approved drug since it went public in 2014.
Wall Street analysts cheered the approval, calling it a significant win for the stock and expecting a strong drug launch for the company. Soleno expects the pill to be available in the US starting in April.
“We think the drug’s well-positioned to launch strongly into what we see as a blockbuster opportunity,” Stifel analyst James Condulis wrote in a note to clients while also recommending investors own the stock.
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