Rhythm Pharmaceuticals’ (RYTM) shares gained 8.4% on Aug. 26 after announcing the FDA’s acceptance of the supplemental new drug application (sNDA) for its only marketed drug, Imcivree (setmelanotide), to treat obesity in children as young as two years old, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 26, 2024.Imcivree, an MC4R agonist, is already approved in the United States and EU for ...