Prader-Willi syndrome is a genetic condition characterized by hyperphagia (insatiable hunger) that affects a child’s metabolism, body, and behavior.
The company says Vykat XR is the first approved therapy to address hyperphagia in individuals with Prader-Willi syndrome.
Soleno expects Vykat XR to be available in the U.S. in April 2025.
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The FDA approval of Vykat XR was based on an adequate and well-controlled study and safety data from the comprehensive clinical development program.
Efficacy was established during the 16-week randomized withdrawal study period of Study 2-RWP (Study C602-RWP), a Phase 3 trial.
Individuals randomized to switch to placebo demonstrated a statistically significant worsening of hyperphagia (compared with individuals who remained on Vykat XR.
Vykat XR has a well-established safety profile with over four years of data across four studies.
In November, the FDA extended the review period for the New Drug Application for DCCR (diazoxide choline) to March 27, 2025.
Price Action: SLNO stock is up 37.8% at $67.50 during the premarket session at the last check Thursday.
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