Tiny Silicon Valley Drugmaker Soars On FDA Win To Deal With Endless Starvation

By Angel Adegbesan | Bloomberg

Soleno Therapeutics jumped on Thursday after the drugmaker received US approval for its drug to deal with insatiable starvation brought on by a genetic dysfunction.

Shares of the Redwood Metropolis, California-based firm climbed 38% — the largest one-day acquire since September 2023 — to their highest stage in additional than eight years.

The Meals and Drug Administration accepted Soleno’s tablet to deal with hyperphagia — a situation the place people have a way of being hungry on a regular basis and by no means feeling glad — in adults and youngsters 4 years or older. The situation is a characteristic of a genetic dysfunction referred to as Prader-Willi syndrome — which has no treatment and impacts one in each 10,000 to 30,000 youngsters, in accordance with the Nationwide Institutes of Well being.

Referred to as Vykat XR, the drug is the primary remedy to notch regulatory approval to handle the acute starvation that’s related to Prader-Willi. The regulatory win additionally marks a milestone for Soleno, as it’s the firm’s first accepted drug because it went public in 2014.

Wall Avenue analysts cheered the approval, calling it a major win for the inventory and anticipating a robust drug launch for the corporate. Soleno expects the tablet to be obtainable within the US beginning 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 word to purchasers whereas additionally recommending buyers personal the inventory.

Extra tales like this can be found on bloomberg.com

Initially Printed: March 28, 2025 at 7:34 AM PDT

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