Business
Rhythm Pharmaceuticals Reports Second Quarter 2020 Financial Results
-- Appointed David Meeker, M.D., as President and Chief Executive Officer – -- FDA granted rare pediatric disease designations for setmelanotide for the
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Appointed David Meeker, M.D., as President and Chief Executive Officer –\n -- 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 -- BOSTON, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today reported financial results and provided a business update for the second quarter ended June 30, 2020. “Rhythm has made tremendous regulatory and clinical progress on its path to bring the first approved therapy to individuals living with rare genetic disorders of obesity,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “The potential approval of setmelanotide for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities will validate the melanocortin-4 receptor (MC4R) pathway as an important therapeutic target, and we look forward to furthering our ongoing efforts, with pivotal data from our Phase 3 clinical trial in Bardet-Biedl syndrome (BBS) and Alström syndromes expected in the fourth quarter or early in 2021 and the continued expansion of our ongoing Phase 2 Basket study.” Dr. Meeker continued, “We are energized by the opportunity to help individuals living with rare genetic disorders of obesity, who currently have no meaningful treatment options for their severe obesity or insatiable hunger. Looking ahead, we are eager to complete our transformation into an integrated, patient-focused organization while continuing to advance our community building and patient engagement efforts.” Second Quarter 2020 and Recent Business Highlights: Pipeline and Recent Developments: POMC and LEPR Deficiency Obesities In July, Rhythm announced the submission of its Marketing Authorization Application (MAA) to the European Medicines Agency...