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Rhythm Pharmaceuticals, Inc. develops and commercializes therapies for rare neuroendocrine diseases, centered on IMCIVREE (setmelanotide), an MC4R agonist for hyperphagia and severe obesity linked to rare MC4R pathway disorders. Company updates commonly cover U.S. and international commercialization of setmelanotide, regulatory authorizations and label expansions for acquired hypothalamic obesity, Bardet-Biedl syndrome, POMC/PCSK1 deficiency and LEPR deficiency, and safety information tied to approved uses.
Rhythm news also follows clinical data from setmelanotide studies, including acquired hypothalamic obesity and genetically caused MC4R pathway diseases, along with development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism. Recurring corporate items include financial results, specialty-pharmacy access arrangements, healthcare conference presentations and board governance changes.
Rhythm Pharmaceuticals (Nasdaq:RYTM) has appointed Jennifer Chien as Executive Vice President, Head of North America, effective November 9, 2020. Ms. Chien, with over 20 years in rare diseases, will co-lead global commercial strategies alongside newly appointed EVP, Head of International, Yann Mazabraud. This leadership change comes as Rhythm prepares for the potential approval of setmelanotide, a therapy for rare genetic obesity disorders. The FDA has set a PDUFA date of November 27, 2020, for Rhythm's New Drug Application for setmelanotide.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the appointment of Yann Mazabraud as Executive Vice President, Head of International, effective October 5, 2020. This organizational change aims to enhance the company's global strategy, particularly for its lead product, setmelanotide, which targets severe obesity linked to rare genetic disorders. Dr. Meeker praised Mazabraud's extensive experience in the biopharmaceutical sector. Additionally, Nithya Desikan, the previous CCO, will leave to pursue other opportunities, while a search for a Head of North American Operations is underway.
BOSTON, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals (Nasdaq: RYTM) announced participation in two investor conferences this September. At the Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020, David Meeker, M.D., will speak at 3:30 p.m. ET. On September 17, 2020, CFO Hunter Smith will present at the Cantor Virtual Global Healthcare Conference at 2:00 p.m. ET. Live webcasts of both events will be accessible on the company's website, with replays available for 30 days following each presentation.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a corporate overview presentation at the Canaccord Genuity 40th Annual Growth Conference on August 13, 2020, at 9:30 a.m. ET. The company's leadership, including David Meeker, M.D., and Hunter Smith, will present insights on developing therapies for rare genetic disorders of obesity. Rhythm's investigational drug, setmelanotide, has FDA filing acceptance for certain obesity conditions with a PDUFA date of November 27, 2020. A live audio webcast will be accessible on their website, with a replay available for 30 days.
Rhythm Pharmaceuticals (Nasdaq: RYTM) has appointed David Meeker, M.D. as the new President and CEO, taking over from Hunter Smith, who remains CFO. Dr. Meeker, a seasoned leader in biopharmaceuticals with extensive experience in rare genetic diseases, aims to enhance the company’s strategy as it approaches potential FDA approval for setmelanotide, targeting POMC and LEPR deficiency obesity. The FDA has set a PDUFA goal date of November 27, 2020, for the drug's NDA. Meeker has been with Rhythm since 2015 and has a strong background in launching therapies for rare diseases.
Rhythm Pharmaceuticals announced promising results from its Phase 2 study of setmelanotide, a treatment for obesity and hyperphagia in individuals with Bardet-Biedl syndrome (BBS). Published in Diabetes, Obesity and Metabolism, the study shows that setmelanotide effectively reduced body weight and hunger. This marks the first Phase 2 trial of any investigational drug showing such efficacy for BBS. The company prepares for topline data from its pivotal Phase 3 trial on setmelanotide, expected by early 2021, further advancing treatment options for this ultra-rare genetic disorder.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced promising interim data from a Phase 2 study of its once-weekly formulation of setmelanotide, aimed at treating rare genetic disorders of obesity. The study found that the weekly formulation achieved weight loss comparable to the daily formulation, with both being safe and well-tolerated. A total of 75 participants were included in the interim analysis, showing no serious adverse events. The company is continuing to analyze the data and aims to discuss registration steps with the FDA, targeting a more convenient treatment option for patients.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that Hunter Smith, Interim CEO and CFO, and Dr. Murray Stewart, CMO, will participate in a fireside chat at the 2020 BofA Securities Health Care Conference on May 12, 2020, at 8:20 a.m. ET. A live audio webcast will be available on Rhythm's website, with a replay accessible for 30 days after the event. The company focuses on developing therapies for rare genetic disorders of obesity and is advancing its lead candidate, setmelanotide, through pivotal clinical trials, with topline data expected in late 2020 or early 2021.