The U.S. Food and Drug Administration (FDA) on Wednesday approved Soleno Therapeutics, Inc.’s Vykat XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS).

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 the fourth-quarter earnings release, the company said it continued strengthening the commercial organization in preparation for the anticipated U.S. launch of DCCR. Strategic investments in key commercial and medical affairs programs, including disease state and payor education, data analytics, and support infrastructure, are well underway.

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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