Rhythm Pharmaceuticals reported their Q3 2020 financial results, highlighting progress towards potential approval of setmelanotide and upcoming clinical milestones.
NDA for setmelanotide for POMC and LEPR deficiency obesities is under review, with a PDUFA goal date of November 27, 2020.
Jennifer Chien and Yann Mazabraud were appointed to co-lead global integrated commercial strategies.
Topline data from the pivotal Phase 3 trial in Bardet-Biedl and Alström syndromes is expected late in the fourth quarter of 2020 or early in the first quarter 2021.
Data from multiple cohorts in the ongoing Phase 2 basket study are planned to be announced early in the first quarter 2021.
Rhythm Pharmaceuticals anticipates potential approval of setmelanotide and key readouts across the next wave of indications.