Rhythm Pharmaceuticals announces key upcoming milestones

Rhythm expects to achieve the following near-term milestones: Secure market access and launch IMCIVREE in Germany for BBS in the second quarter of 2023, pending reimbursement negotiations with German authorities; Rhythm also anticipates launching IMCIVREE for BBS in The Netherlands in the second half of 2023, pending local negotiations; Complete regulatory review by Health Canada and, pending approval, make IMCIVREE commercially available in Canada for the treatment of BBS, or POMC, PCSK1 or LEPR deficiencies in the second half of 2023; Initiate a Phase 3, randomized, double-blind trial in patients naive to setmelanotide therapy ("de novo study") to evaluate the weekly formulation of setmelanotide in patients with BBS in the second half of 2023; Announce preliminary data from the open-label part of the Phase 2 DAYBREAK trial from one or more genetically defined cohorts in the second half of 2023; Announce topline data from the ongoing Phase 3, open-label pediatrics trial evaluating one year of setmelanotide therapy in patients with MC4R pathway deficiencies between the ages of 2 and 6 years old in the second half of 2023; and Announce topline data from the ongoing Phase 3 switch trial evaluating a weekly formulation of setmelanotide in the second half of 2023.