The U.S. Food and Drug Administration approved Rhythm Pharmaceuticals Inc.'s (RYTM) supplemental New Drug Application or sNDA for Imcivree or setmelanotide, a melanocortin-4 receptor agonist, for patients with Bardet-Biedl syndrome or BBS, the company said in a statement on Thursday.
Meanwhile, the FDA issued a complete response letter for the sNDA for setmelanotide in Alström syndrome. The company plans to reevaluate potential paths forward in Alström syndrome in the U.S.
RYTM closed Thursday regular trading at $3.90 up $0.45 or 13.04%. However, in the after-hours trade, the stock dropped $0.50 or 12.82%.
With the FDA approval, Imcivree is indicated for chronic weight management in adult and pediatric patients 6 years old and older with monogenic or syndromic obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency, or BBS.
Bardet-Biedl syndrome is a rare genetic disease that affects approximately 1,500-2,500 people in the U.S. People living with BBS may experience insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life.
The approval was based on phase 3 trial results that demonstrated statistically significant reductions in weight and hunger in patients with Bardet-Biedl syndrome.
Imcivree was initially approved by the FDA in November 2020 for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency. Imcivree's label was updated Thursday to include an FDA-approved test developed under a post-marketing commitment to confirm variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
The company noted that Imcivree is not indicated for the treatment of patients with obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 or LEPR variants classified as benign or likely benign, or other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general obesity.
The company also announced the launch of Rhythm InTune, a program that provides personalized support for individuals living with rare genetic diseases of obesity. Rhythm InTune provides education and resources tailored to fit each patient's unique need, with a dedicated patient education manager as a single point of contact.
For comments and feedback contact: editorial@rttnews.com
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.