Rhythm Pharmaceuticals (NASDAQ: RYTM) reported Q1 EPS of ($0.84), $0.08 worse than the analyst estimate of ($0.76).

• Announced updated clinical data from Phase 2 basket study of setmelanotide in MC4R pathway heterozygous (HET) obesity, demonstrating consistent weight and hunger responses in patients with high-impact loss-of-function (LOF) variants
• Announced strategy for further development in HET obesity with patients stratified into cohorts based on LOF variant
• Topline data from pivotal Phase 3 trials evaluating setmelanotide in pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesity expected in the third quarter of 2019, followed by New Drug Application (NDA) filings

“In the first quarter, we announced preliminary data and an updated clinical strategy in patients with HET obesity, which represents key progress as we seek to expand our pipeline into additional MC4R pathway deficiency obesities that may be setmelanotide-responsive. In parallel, we detailed ongoing efforts to leverage the Rhythm Engine -- comprised of our Phase 2 basket study, TEMPO Registry and GO-ID genotyping study -- to accelerate patient identification and develop a better understanding of the burden in people living with rare genetic disorders of obesity,” said Keith Gottesdiener, M.D., Chief Executive Officer of Rhythm. “We are now preparing for topline data readouts from our two ongoing pivotal Phase 3 trials of setmelanotide in POMC and LEPR deficiency obesities and the potential filing of our first NDAs with the U.S. Food and Drug Administration (FDA). In parallel, we are broadening our community engagement to support the potential launch of setmelanotide. We expect 2019 to be a transformative year for Rhythm, as we progress closer to our vision of delivering the first approved therapeutic for people living with rare genetic disorders of obesity.”

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