Rhythm Pharmaceuticals Inc.’s (RYTM) New Drug Application for Setmelanotide is under priority review by the FDA, with a decision anticipated on November 27, 2020.Setmelanotide, an investigational, melanocortin-4 receptor agonist, is proposed for the treatment of two ultra-rare types of genetic obesity - pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. POMC deficiency obesity is a disorder caused by variants in the POMC or PCSK1 genes that can often lead to severe obesity beginning early in life and insatiable hunger, in addition to endocrine abnormalities, and sometimes red hair and light skin pigmentation. LEPR deficiency obesity is a disorder caused by variants in the LEPR gene that can often lead to severe obesity beginning early in life and insatiable hunger, in addition to endocrine abnormalities. It is estimated that in the U.S., there are approximately 100 to 500 patients with POMC deficiency obesity and about 500 to 2,000 patients with LEPR deficiency obesity. Currently, there are no approved treatments for reducing body weight and hunger.RYTM closed Friday’s (Oct.23, 2020) trading at $22.62, down 6.10%.