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A Prescription Drug User Fee Act target date of December 20, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) ...

Hypothalamic obesity (HyOb) develops when brain damage or conditions like Prader-Willi syndrome disrupt the hypothalamus, impairing hunger and energy regulation. Traditional calorie-based weight-loss ...

Please provide your email address to receive an email when new articles are posted on . Setmelanotide plus concomitant GLP-1 therapy lowered BMI in children and adults with hypothalamic obesity.

Before GLP-1 agonists became the blockbuster obesity drugs many people know and use today, Rhythm Pharmaceuticals was researching molecules that take a similar approach but for a different target. The ...

Obesity associated with hypothalamic dysfunction was initially described in patients with craniopharyngioma. Hypothalamic obesity may also result from brain radiation, infection (eg, tuberculosis), ...

Setmelanotide treatment over a 16-week period leads to a consistent decrease in both bodyweight and hunger among patients with hypothalamic obesity, according to the results of the first known study ...

Findings showed patients on setmelanotide saw a mean BMI reduction of 16.5% from baseline compared with a 3.3% increase for those on placebo at week 52. Topline data were announced from a phase 3 ...

The last time I spoke about Rhythm Pharmaceuticals, Inc. (RYTM) it was in a Seeking Alpha article entitled "Rhythm: Late-Stage Study Win Brings About Change For Rare Obesity Disorder." With respect to ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved an expanded indication for setmelanotide for acquired hypothalamic obesity. The drug conferred ...

Setmelanotide, an investigational melanocortin-4 receptor agonist, reduced body mass index (BMI) by a mean 15% at 16 weeks and 26% at 12 months in people with hypothalamic obesity in a phase II ...