Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) shares are down during Tuesday’s premarket session following the Monday announcement of topline results from its EMANATE trial.

EMANATE was a Phase 3 trial designed to evaluate the efficacy and safety of setmelanotide in patients with rare, genetically driven obesities of the MC4R pathway.

EMANATE Trial Misses Primary Endpoints

In the EMANATE trial, Rhythm Pharmaceuticals revealed that the primary endpoints were not met.

Though the post hoc analyses indicated that setmelanotide achieved statistically significant BMI reductions in patients with obesity due to specific genetic variants at the 52-week mark.

Rhythm Pharmaceuticals Pipeline Focus Shifts To Next-Generation Assets

The company plans to continue analyzing the dataset and exploring potential clinical development paths for its next-generation MC4R agonists.

Additionally, no new safety signals were observed with setmelanotide, and the safety profile remained consistent with prior studies.

Rhythm plans to continue the analysis of the EMANATE dataset and evaluate potential clinical development paths forward with SRC1 (NCOA1) and POMC with its next-generation MC4R agonists bivamelagon ...