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Jun 30, 2020
Rhythm Pharmaceuticals Q2 2020 Earnings Report
Reported financial results for the second quarter ended June 30, 2020 and provided a business update.
Key Takeaways
Rhythm Pharmaceuticals reported tremendous regulatory and clinical progress with setmelanotide. FDA granted rare pediatric disease designations for setmelanotide to treat POMC and LEPR deficiency obesities. The company also submitted MAA to EMA and received FDA acceptance of NDA for setmelanotide in POMC and LEPR deficiency obesities.
FDA granted rare pediatric disease designations for setmelanotide for the treatment of POMC and LEPR deficiency obesities
Submitted MAA to EMA for setmelanotide in POMC and LEPR deficiency obesities
Received FDA acceptance of NDA for setmelanotide for POMC and LEPR deficiency obesities for filing; assigned PDUFA goal date of November 27, 2020
On track to announce topline data from pivotal Phase 3 trial of setmelanotide in BBS and Alström syndrome in fourth quarter of 2020 or early in the first quarter of 2021
Rhythm Pharmaceuticals
Rhythm Pharmaceuticals
Forward Guidance
Rhythm is on track to report topline data from its combined pivotal Phase 3 trial evaluating setmelanotide in BBS and Alström syndrome in the fourth quarter of 2020 or early in the first quarter of 2021. Rhythm expects to announce additional data in 2020 from its ongoing Phase 2 Basket Study of setmelanotide in high-impact heterozygous (HET) obesity and additional data from one or more of the other disorders being studied in its Phase 2 Basket Study. Rhythm expects to provide an update on its genetic sequencing efforts in 2020.