13 May 2020 - FDA grants priority review of application and sets PDUFA goal date of 27 November 2020.

Rhythm Pharmaceuticals today announced that the U.S. FDA has accepted the company's new drug application for setmelanotide, an investigational, melanocortin-4 receptor agonist, for the treatment of pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity. 

At this time, the FDA has indicated that it is not planning an advisory committee meeting as part of the NDA review.