Business
Rhythm Pharmaceuticals Reports First Quarter 2020 Financial Results
-- Completed rolling NDA submission to FDA for setmelanotide in POMC and LEPR deficiency obesities; on track to submit MAA to EMA in the second quarter of
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Completed rolling NDA submission to FDA for setmelanotide in POMC and LEPR deficiency obesities; on track to submit MAA to EMA in the second quarter of 2020 –\n -- Received Orphan Drug Designation from FDA for setmelanotide for the treatment of Alström syndrome -- -- Continues to expect topline data from pivotal Phase 3 trial of setmelanotide in Bardet-Biedl and Alström syndromes in fourth quarter of 2020 or early in the first quarter of 2021 -- BOSTON, May 04, 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 first quarter ended March 31, 2020. “We are excited about the completion of our first New Drug Application (NDA) submission, which marks a critical next step towards bringing a potentially life-changing medicine to individuals living with rare genetic disorders of obesity,” said Hunter Smith, interim Chief Executive Officer and Chief Financial Officer of Rhythm. “We are especially proud of how our Rhythm community, including our employees, the clinical staff at our trials sites, and the patients and families involved in our studies, has endured and met the unprecedented challenges brought on by the novel coronavirus pandemic, enabling our ongoing efforts to advance the development of setmelanotide with minimal interruption.” Murray Stewart, M.D., Chief Medical Officer of Rhythm, said, “We are grateful for the support and dedication of the staff at the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) during these trying times, as their commitment to a consistent dialogue during the pandemic has supported the progression of our first NDA submission and our planned submission of a Marketing Authorization Application (MAA). As we move toward the potential commercialization of setmelanotide, our team is focused on identifying patients and advancing key pre-commercial activities across Rhythm. Looking ahead, we anticipate additional data from our Phase 2 Basket Study this year and remain on track to report topline data from our pivotal Phase 3 trial in Bardet-Biedl syndrome (BBS) and Alström syndrome in the fourth quarter of 2020 or early in the first quarter of 2021....