- Soleno Therapeutics’ (SLNO) stock jumped over 40% to $68.72 after the FDA approved VYKAT XR, a new daily tablet to control extreme hunger (hyperphagia) in people with Prader-Willi syndrome, set to be available in April 2025.
- Studies over four years, including a 16-week test showing better hunger control with VYKAT XR versus placebo, confirmed its effectiveness, though side effects like extra hair growth and high blood sugar affected 10% or more of users.
Soleno Therapeutics (SLNO), a $2.25 billion pharmaceutical company, saw its stock soar over 40% to $68.72 in early trading Thursday after the U.S. Food and Drug Administration gave the green light to VYKAT XR, a new medication for people with Prader-Willi syndrome. This condition, known as PWS, affects both kids as young as 4 and adults, causing an intense, uncontrollable hunger called hyperphagia that can make daily life incredibly tough. VYKAT XR, which used to go by the name DCCR, is a once-a-day tablet made from diazoxide choline, and it’s set to hit the U.S. market in April 2025, offering a glimmer of hope to families who’ve been desperate for help.
The FDA’s decision came after a solid study showed VYKAT XR really works. In a 16-week test called Study 2-RWP, researchers split people with PWS into two groups: one kept taking VYKAT XR, while the other switched to a placebo—a pill with no medicine in it. The folks who stayed on VYKAT XR did much better, with their extreme hunger staying under control, while those on the placebo saw their hunger get worse. Before this test, everyone involved had been taking VYKAT XR for an average of 3.3 years, either in secret tests where no one knew who got the real drug or in open tests where everyone did, giving researchers a long look at how it performs.
Safety-wise, VYKAT XR has been studied for over four years across four different trials, including a key one called Study 1. The data shows it’s generally safe, though some people – 10% or more – had side effects like extra hair growth (hypertrichosis), swelling (edema), high blood sugar (hyperglycemia), or a rash, all happening at least 2% more often than in the placebo group. Stacy Ward, the head of the Prader-Willi Syndrome Association | USA, called this approval a game-changer, pointing out how hyperphagia disrupts lives and how VYKAT XR could finally ease that burden. With this new drug, Soleno Therapeutics is stepping up to tackle a problem that’s been ignored for too long, backed by years of research and a clear need in the PWS community.
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