IMCIVREE (setmelanotide) — PDUFA
H2 2026
Decision by Japan's PMDA for IMCIVREE in acquired HO anticipated in the second half of 2026;Source filing
RYTM biotech catalysts & pipeline
RHYTHM PHARMACEUTICALS INC · Data as of 2026-09-08
Upcoming catalysts
IMCIVREE (setmelanotide) — Regulatory decision
H2 2026
The Company anticipates the Committee for Medicinal Products for Human Use (CHMP) would issue an opinion to the European Commission (EC) in the second quarter of 2026 with potential marketing authorization in the second half of 2026.Source filing
IMCIVREE (setmelanotide) — Conference presentation
Sep 8–Sep 10
Long-term weight outcomes of setmelanotide in pediatric participants with Bardet-Biedl syndrome or with POMC or LEPR deficiency and obesity;Source filing