{"id":521948,"date":"2021-08-03T07:05:04","date_gmt":"2021-08-03T11:05:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/rhythm-pharmaceuticals-reports-second-quarter-2021-financial-results\/"},"modified":"2021-08-03T07:05:04","modified_gmt":"2021-08-03T11:05:04","slug":"rhythm-pharmaceuticals-reports-second-quarter-2021-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/rhythm-pharmaceuticals-reports-second-quarter-2021-financial-results\/","title":{"rendered":"Rhythm Pharmaceuticals Reports Second Quarter 2021 Financial Results"},"content":{"rendered":"
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\n — Received European Commission authorization of IMCIVREE for treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiencies\u00a0—
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\n — Setmelanotide selected for evaluation as a \u201cHighly Specialised Technology\u201d by Great Britain\u2019s National Institute for Health and Care Excellence\u00a0—
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\n — On track to submit sNDA to FDA and MAA Type II amendment to EMA for setmelanotide in BBS and Alstr\u00f6m syndromes in 2H 2021 —
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\n — Five new Phase 2 and 3 clinical trials planned to initiate in 2H 2021 —
<\/em>— Management to host conference call at 8 a.m. ET\u00a0—<\/em><\/p>\n

BOSTON, Aug. 03, 2021 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc.\u00a0(Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today reported financial results and provided a business update for the second quarter ended June 30, 2021.<\/p>\n

\u201cWe have made tremendous progress in the second quarter towards our goal of transforming the care of patients with rare genetic diseases of obesity globally,\u201d said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. \u201cWe are pleased with our first full quarter of IMCIVREE\u00ae<\/sup> (setmelanotide) commercial availability in the United States with positive engagements with patients, prescribers and payors. We recently secured European Commission marketing authorization for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above, enabling us to expand patient access to IMCIVREE. From a market access standpoint, we are encouraged that regulatory authorities, such as National Institute for Health and Care Excellence (NICE) in the United Kingdom, recognize these obesities as rare genetic diseases for which there are no available treatment options.\u201d<\/p>\n

Dr. Meeker continued, \u201cIn parallel, we are executing on our clinical development and regulatory strategy to bring setmelanotide to substantially more patients suffering from rare genetic diseases of obesity. We look forward to completing supplementary regulatory submissions in the second half of this year to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking marketing authorization for setmelanotide for Bardet-Biedl and Alstr\u00f6m syndromes, and we are excited to continue advancing our broad clinical development program in additional patient populations. With agreement from both the FDA and EMA, we are poised to initiate five clinical trials of setmelanotide: the pivotal Phase 3 EMANATE trial with five sub-studies in heterozygous POMC, PCSK1 or LEPR deficiency obesities and SRC1 and SH2B1 deficiency obesities, the Phase 2 DAYBREAK trial in 31 additional genes each with strong or very strong ties to the MC4R pathway, as well as a Phase 3 pediatrics trial for children younger than 6 and two registrational trials for our weekly formulation of setmelanotide. Taken together, we believe these efforts may enable us to help many more people with rare genetic diseases of obesity with a potential treatment for their insatiable hunger or hyperphagia and early-onset, severe obesity.\u201d<\/p>\n

\n Second Quarter and Recent Business Highlights:<\/strong>\n <\/p>\n

\n Pipeline and Business Developments:<\/strong>\n <\/p>\n

\n POMC and LEPR Deficiency Obesities:<\/em>\n <\/p>\n