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Rhythm PHARMACEUTICALS Rhythm Pharmaceuticals Reports Third Quarter 2021 Financial Results November 2 , 2021 -- U.S. and EU regulatory filings submitted for IMCIVREEⓇ ( setmelanotide ) for treatment of Bardet - Biedl and Alström syndromes ; launch preparations underway -- -- Delivered a total of 22 presentations at three major medical conferences -- -- New presentations include first - ever data showing improvements in health - related quality of life in rare genetic diseases of obesity -- -- IMCIVREE third quarter net sales reach $ 1M -- -- Management to Host Conference Call at 8:00 a.m. ET -- BOSTON , Nov. 02 , 2021 ( GLOBE NEWSWIRE ) -- Rhythm Pharmaceuticals , Inc. ( 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 third quarter ended September 30 , 2021 . " We continue to execute across our expanding integrated clinical and commercial strategy to deliver setmelanotide and its potential clinical benefit to patients with rare genetic diseases of obesity , " said David Meeker , M.D. , Chair , President and Chief Executive Officer of Rhythm . " Our team completed regulatory submissions in both the United States and European Union recently , positioning IMCIVREEⓇ ( setmelanotide ) as the first - ever therapy to address the unmet needs of hyperphagia and severe obesity that affect the lives of patients and families living with Bardet - Biedl and Alström syndromes . Our initial U.S. commercial experience with POMC , PCSK1 , and LEPR deficiency obesities continues to provide valuable learnings as we expand the number of health care providers testing patients with early - onset , severe obesity and hyperphagia and work with payers to ensure patients who need therapy can access it . With effective patient services in place , patients have achieved positive responses and stayed on therapy . We believe these commercial achievements provide a strong foundation for a successful launch in BBS and Alström syndrome in mid - 2022 . " Dr. Meeker continued , " In parallel , we continue to advance our robust development strategy for setmelanotide . Including this week's The Obesity Society's ObesityWeek Ⓡ , we recently delivered a total of 22 presentations that support setmelanotide's potential ability to improve the lives of patients and the families who care for them . With updated sequencing data from our Uncovering Rare ObesityⓇ ( URO ) testing program complementing presentations on efficacy and improved quality of life data , we have strong confidence in setmelanotide's potential to deliver meaningful benefit and our ability to identify patients . We look forward to continuing to execute across our pipeline and deliver on our promise to transform the care and treatment of rare genetic diseases of obesity . " Third Quarter and Recent Business Highlights : Regulatory Updates : Bardet - Biedl Syndrome and Alström Syndrome : • In October , Rhythm announced the completion of its Type II variation application to the European Medicines Agency ( EMA ) for IMCIVREE for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with BBS or Alström syndrome . • In September , Rhythm announced the completion of its supplemental New Drug Application ( sNDA ) to the U.S. Food and Drug Administration ( FDA ) for IMCIVREE for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with BBS or Alström syndrome . Rhythm requested priority review for the application , which , if granted , could provide a target FDA review period of six - months from the date the sNDA is accepted . • Also in September , Rhythm announced an Expanded Access Program ( EAP ) for setmelanotide for the treatment of eligible patients in the United States with severe obesity and hyperphagia due to BBS . The FDA's expanded access regulations are designed to facilitate access to an investigational therapy to treat patients who are unable to participate in clinical trials and have serious or immediately life - threatening diseases or conditions for which there are no comparable or satisfactory alternative treatment options . POMC and LEPR Deficiency Obesities : • In September , Rhythm announced that Great Britain's Medicines & Healthcare Products Regulatory Agency ( MHRA ) has granted marketing authorisation to IMCIVREE 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 . Clinical Development Updates • This week at ObesityWeek , Rhythm delivered multiple data presentations including : the first - ever health - related quality of