08:57 AM EDT, 08/26/2024 (MT Newswires) -- Rhythm Pharmaceuticals ( RYTM ) said Monday the US Food and Drug Administration has accepted the company's supplemental New Drug Application for Imcivree to treat obesity due to Bardet-Biedl syndrome or pro-opiomelanocortin in children as young as 2 years old.

The company said the submission is based on data from a phase 3 trial of patients aged 2 to 6 years old with obesity due to biallelic deficiency or a clinical diagnosis of BBS.

The FDA has granted Priority Review of the application and assigned a Prescription Drug User Fee Act goal date of Dec. 26.

Shares of Rhythm Pharmaceuticals ( RYTM ) were up 5.6% in recent Monday premarket activity.

Price: 48.70, Change: +2.58, Percent Change: +5.59