RYTM Rhythm

Rhythm Pharmaceuticals: FDA approves IMCIVREE for acquired hypothalamic obesity

FDA approved IMCIVREE (setmelanotide) on March 19, 2026 for acquired hypothalamic obesity. More than 150 patient start forms were received in the first six weeks post-approval. European Commission also granted marketing authorization for the same indication.

Rhythm Pharmaceuticals: EMANATE Phase 3 topline results miss primary endpoints

The four EMANATE Phase 3 substudies evaluating setmelanotide in heterozygous MC4R-pathway obesities failed to meet their pre-specified primary endpoints for BMI reduction at 52 weeks. Post-hoc analyses showed statistically significant BMI reductions in the POMC/PCSK1 and SRC1 (NCOA1) substudies, but these are exploratory and not regulatory-grade. Rhythm will use the data to refine variant selection and guide next-generation MC4R agonist development.

Rhythm sets March 20, 2026 PDUFA for setmelanotide sNDA in acquired HO

FDA accepted the sNDA for setmelanotide in acquired hypothalamic obesity and assigned a PDUFA goal date of March 20, 2026. Additional 52-week data from the TRANSCEND trial (N=142) showed an 18.8% placebo-adjusted BMI reduction, reinforcing the pivotal dataset. The company will submit the final data package on March 2, 2026.

Rhythm sets March 20, 2026 PDUFA for setmelanotide sNDA in acquired HO

FDA assigned a March 20, 2026 PDUFA goal date for the supplemental NDA seeking approval of setmelanotide in acquired hypothalamic obesity. The company stated it is prepared to launch IMCIVREE in the U.S. for this indication pending FDA approval.

Rhythm sets March 20, 2026 PDUFA for setmelanotide sNDA in acquired HO

The document establishes a March 20, 2026 PDUFA goal date for the supplemental NDA seeking approval of setmelanotide in acquired hypothalamic obesity. This is the next regulatory decision point for expanding the drug’s label beyond its current indications. The company also confirmed two Phase 3 topline readouts (Japanese HO cohort and EMANATE trial) are expected in Q1 2026.

Rhythm Pharmaceuticals: FDA extends IMCIVREE sNDA PDUFA to March 20, 2026

FDA extended the PDUFA goal date for the setmelanotide sNDA in acquired hypothalamic obesity from December 20, 2025 to March 20, 2026 after classifying a major amendment. The amendment consists only of additional sensitivity analyses of Phase 3 efficacy data; no new safety or manufacturing data were requested.

Rhythm sets Dec 20, 2025 PDUFA for setmelanotide sNDA in acquired HO

FDA accepted the sNDA for setmelanotide in acquired hypothalamic obesity and granted Priority Review. A PDUFA goal date of December 20, 2025 has been assigned, establishing a near-term regulatory decision point for the new indication.