Rhythm(US:RYTM)2023-02-10 16:06Commercial Performance & Market Access - IMCIVREE launched for BBS in the U S following FDA approval in June[9] - Achieved access in eight international markets in 2022[8] - Over 120 BBS prescriptions have been written[20] - Over 40 approvals for reimbursement have been granted[21] - Approximately 100 individuals with BBS have been identified in EU4 + UK[27] Clinical Development Programs - Phase 3 trial in pediatric patients with MC4R pathway diseases is fully enrolled[4] - A Phase 3 trial for weekly formulation de novo is planned[4] - Phase 3 trial in hypothalamic obesity is planned for 1Q2023[88] - Phase 3 EMANATE trial is underway, targeting 53000 patients in the U S with heterozygous POMC/PCSK1 insufficiency, heterozygous LEPR insufficiency, SRC1 deficiency and SH2B1 deficiency[15,89] - Preliminary data from Phase 2 DAYBREAK trial has been released[10] Financial Status - A non-dilutive RIFA agreement with HealthCare Royalty for up to $100 million has been entered[4] - Cash on hand is expected to be sufficient to fund operations into 2025[93] - Cash, cash equivalents, and short-term investments totaled $347.8 million as of September 30, 2022[107]