{"success":true,"data":{"pressRelease":{"id":"31355","rtpr_id":"nGNX3Kh1Bt","ticker":"RYTM","exchange":"NASDAQ","all_tickers":["RYTM"],"title":"Rhythm Pharmaceuticals Announces New Data Presentations at the 2026 European Congress of Endocrinology","author":"Globe Newswire","published_at":"2026-05-12T12:00:02.226Z","article_body":"– Real world data showed clinically meaningful BMI reductions with\nsetmelanotide in 62 adults with 12-month data living with acquired\nhypothalamic obesity (HO) in France –\n\n– Phase 3 analyses demonstrated improvements across multiple cardiometabolic\nrisk indices with setmelanotide in acquired HO –\n\n– New research highlights the burden and under recognition of hyperphagia\n–\n\nBOSTON, May 12, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:\nRYTM), a global commercial-stage biopharmaceutical company focused on\ntransforming the lives of patients living with rare neuroendocrine diseases,\ntoday announced that Rhythm and its collaborators will present six posters,\nincluding four featuring new data, relating to the company’s work with\nsetmelanotide at The European Congress of Endocrinology (ECE), taking place\nMay 9-12, 2026 in Prague.\n\n“Obesity due to rare neuroendocrine diseases is often accompanied by\nhyperphagia and severe metabolic complications that significantly affect\npatients’ health and daily lives,” said David Meeker, M.D., Chairman,\nChief Executive Officer and President of Rhythm Pharmaceuticals. “Real-world\ndata generated from the pre-marketing, early-access program in France show\nthat setmelanotide is associated with clinically meaningful improvements not\nonly in body weight, but also improvements across multiple cardiometabolic\nrisk measures and disease-defining features, providing a more comprehensive\npicture of the treatment impact in these diseases.”\n\nReal-World BMI Outcomes in Adult Patients with Acquired Hypothalamic Obesity\nTreated With Setmelanotide for up to 12 Months in France\n\nThis real-world analysis evaluated adults with acquired hypothalamic obesity\n(HO) treated with setmelanotide through France’s early-access program for up\nto twelve months. A total of 62 patients with acquired HO had started\nsetmelanotide therapy, as of November 30, 2025. The results showed that\npatients with acquired HO on setmelanotide achieved significant reductions in\nBMI and meaningful decreases in hunger scores. Key findings include:\n* -13.0% reduction in mean BMI from baseline (p<0.0001) in patients who\nreached 6 months (n=39);\n* -19.6% reduction in mean BMI from baseline (p<0.0001) in patients who\nreached 9 months (n=26);\n* -16.9% reduction in mean BMI from baseline (p<0.0001) in patients who\nreached 12 months (n=25)\n* The majority of patients had a BMI reduction of ≥10% after 6, 9, or 12\nmonths of treatment;\n* Patients achieved improvements in obesity classes with 18.0%, 34.6%, and\n28.0% of patients no longer living with obesity after 6, 9, and 12 months,\nrespectively;\n* Patients aged ≥12 years reported improvements in all four hunger questions\nafter 6, 9, and 12 months of treatment; and\n* No new safety concerns were observed and reported adverse events were\nconsistent with Phase 3 trial data.\nHyperphagia Severity in Adult Patients with Bardet-Biedl Syndrome –\nA Mixed-Methods Cross-Sectional Study in the United Kingdom \n\nThis study evaluated hyperphagia severity in adults with Bardet-Biedl syndrome\n(BBS) and obesity using questionnaires and expert-led interviews. Key findings\ninclude:\n* A total of 39 adults completed the questionnaire and 13 completed the\nsemi-structured, expert-led interviews;\n* Questionnaires alone classified only 7.7% of patients as having severe\nhyperphagia, whereas semi-structured, expert-led interviews classified 69.2%\nof participants as having severe hyperphagia; and\n* 92.3% of participants (12/13) classified a higher severity level by\ninterview compared with only 1 participant showing the same severity\nclassification across both methods.\nThis study suggests a high prevalence of severe hyperphagia in adult patients\nwith BBS and obesity in the UK and indicates substantial underreporting\nwith self-reported questionnaires.\n\nImpact of Setmelanotide on Metabolic Index Scores in Phase 3 Trial\nParticipants with Acquired Hypothalamic Obesity \n\nA post hoc analysis of the Phase 3 TRANSCEND trial assessed the impact of\nsetmelanotide on multiple validated cardiometabolic risk indices at Week 52.\nSetmelanotide treatment in patients with acquired HO led to significant\nimprovements in multiple metabolic index scores versus placebo. Key findings\ninclude:\n* Metabolic syndrome z-score mean change was -0.9 vs -0.2 for the placebo\ngroup (p<0.0001) (n=53 vs n=31)\n* The mean change in Lipid Accumulation Product (LAP) (n=68 vs n=36) from\nbaseline was -36.4 compared to -2.6 for the placebo group (p<0.0001);\n* The mean change in Triglyceride-Glucose Waist Circumference Index (TyG-WC)\n(n=63 vs n=35) was -138.3 vs +21.2 for the placebo group (p<0.0001);\n* The mean change in Visceral Adiposity Index (VAI) (n=67 vs n=35) was -1.5\nvs -0.4 for the placebo group (p=0.0009); and\n* The mean change in the Fatty Liver Index (FLI) (n=65 vs n=35) was -24.2 vs\n+4.4 for the placebo group (p<0.0001).\nThe findings highlight the broad metabolic benefits and strong clinically\nmeaningful efficacy of setmelanotide in this population, supporting its\npotential as a therapeutic option for patients with acquired HO.\n\nRecognising the Burden of Acquired Hypothalamic Obesity in Craniopharyngioma:\nCross-Country Insights from Lived Experiences to Support Integrated Care\nAcross All Life Stages \n\nThis study aimed to highlight the persistent and under-recognized\nhealth burden of acquired HO across life stages, drawing on the experiences\nof individuals with childhood-onset craniopharyngioma (CO-CP) from the\nNetherlands, Germany, and the UK. Findings include:\n* Key disease symptom burden for craniopharyngioma (CP) included pituitary\nhormone dysfunction (100%), thirst and fluid imbalance (87.9%), and weight\ngain (78.8%);\n* Fear of Addisonian crises (90.9%), social stigma (87.9%), and challenges at\nwork/school (87.9%) were reported as the most frequent quality of life\nchallenges associated with CP;\n* Across all three countries, many of the reported disease symptoms were\nassociated with acquired HO, such as hyperphagia, fatigue and reduced stamina,\nand weight gain; and\n* The transition from pediatric to adult care was reported as abrupt,\ninconsistent and fragmented with significant needs and gaps in adult\nfollow-up.\n* Patients with craniopharyngioma require diverse, evolving long-term support\nto address complex medical needs, with greater emphasis on managing acquired\nHO, as many reported symptoms are linked to this condition.\nAdditional Congress Presentations\nTwo encore posters will also be presented at ECE:\n* Efficacy and Safety of Setmelanotide in Acquired Hypothalamic Obesity:\nResults from a Double-Blind, Multicenter, Placebo-Controlled, Randomized Phase\n3 Trial; and\n* Genotype-Phenotype Correlation of Ophthalmic,\nRenal/Genitourinary, Neurological and Neurodevelopmental Manifestations\nin Published Cases of Bardet-Biedl Syndrome. \nThese presentations from ECE 2026 will be available following the\nconference at: https://hcp.rhythmtx.com/publications-presentations/  \n\nAbout Rhythm Pharmaceuticals \nRhythm is a commercial-stage biopharmaceutical company committed to\ntransforming the lives of patients and their families living with rare\nneuroendocrine diseases. Rhythm’s lead asset, IMCIVREE(® )(setmelanotide),\nan MC4R agonist designed to treat hyperphagia and severe obesity, is approved\nby the U.S. Food and Drug Administration (FDA) to reduce excess body weight\nand maintain reduction long term in adults and pediatric patients aged 4 years\nand older with acquired hypothalamic obesity, adult and pediatric patients 2\nyears of age and older with syndromic or monogenic obesity due to Bardet-Biedl\nsyndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including\nproprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin\nreceptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s\nMedicines & Healthcare Products Regulatory Agency (MHRA) have authorized\nsetmelanotide for the treatment of obesity and the control of hunger\nassociated with genetically confirmed BBS or genetically confirmed\nloss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR\ndeficiency in adults and children 2 years of age and above. The European\nCommission (EC) has authorized setmelanotide for the treatment of obesity and\ncontrol of hunger in patients 4 years of age and above with acquired\nhypothalamic obesity. Additionally, Rhythm is advancing a broad clinical\ndevelopment program for setmelanotide in other rare diseases, as well as\ninvestigational MC4R agonists bivamelagon and RM-718, and a preclinical suite\nof small molecules for the treatment of congenital hyperinsulinism. Rhythm’s\nheadquarters is in Boston, MA.\n\nSetmelanotide Indication \nIn the United States, setmelanotide is indicated to reduce excess body weight\nand maintain weight reduction long term in adults and pediatric patients aged\n4 years and older with acquired hypothalamic obesity, in adult and pediatric\npatients aged 2 years and older with syndromic or monogenic obesity due to\nBardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein\nconvertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR)\ndeficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1,\nor LEPR genes that are interpreted as pathogenic, likely pathogenic, or of\nuncertain significance (VUS). \nIn the European Union and the United Kingdom, setmelanotide is indicated for\nthe treatment of obesity and the control of hunger associated with genetically\nconfirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency\nor biallelic LEPR deficiency in adults and children 2 years of age and above.\nIn the European Union and the United Kingdom, setmelanotide should be\nprescribed and supervised by a physician with expertise in obesity with\nunderlying genetic etiology.\n\nPlease refer to the full Summary of Product Characteristics for a complete\nlist of indications, contraindications, warnings and precautions.\n\nLimitations of Use\n\nSetmelanotide is not indicated for the treatment of patients with the\nfollowing conditions as setmelanotide would not be expected to be effective:\n* Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1,\nor LEPR variants classified as benign or likely benign\n* Other types of obesity not related to acquired HO, BBS, or POMC, PCSK1 or\nLEPR deficiency, including obesity associated with other genetic syndromes and\ngeneral (polygenic) obesity.\nImportant Safety Information\n\nCONTRAINDICATIONS\n\nPrior serious hypersensitivity to setmelanotide or any of the excipients in\nIMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been\nreported.\n\nWARNINGS AND PRECAUTIONS\n\nDisturbance in Sexual Arousal: Spontaneous penile erections and increased\nfrequency of penile erections in males have occurred. Inform patients that\nthese events may occur and instruct patients who have an erection lasting\nlonger than 4 hours to seek emergency medical attention.\n\nDepression and Suicidal Ideation: Depression and suicidal ideation have\noccurred. Monitor patients for new onset or worsening depression or suicidal\nthoughts or behaviors. Consider discontinuing IMCIVREE if patients experience\nsuicidal thoughts or behaviors, or clinically significant or persistent\ndepression symptoms occur.\n\nHypersensitivity Reactions: Serious hypersensitivity reactions (e.g.,\nanaphylaxis) have been reported. If suspected, advise patients to promptly\nseek medical attention and discontinue IMCIVREE.\n\nSkin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New\nMelanocytic Nevi: Generalized or focal increases in skin pigmentation occurred\nin the majority of IMCIVREE-treated patients. IMCIVREE may also cause\ndevelopment of new melanocytic nevi or darkening of pre-existing nevi. Perform\na full body skin examination prior to initiation and periodically during\ntreatment to monitor pre-existing and new pigmented lesions.\n\nAcute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and\nsecondary adrenal insufficiency reported serious adverse reactions related to\nacute adrenal insufficiency in 5% of IMCIVREE-treated patients and no\nplacebo-treated patients. In patients with secondary adrenal insufficiency,\nmonitor for clinical signs of acute adrenal insufficiency.\n\nSodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus:\nPatients with acquired HO and concomitant central diabetes insipidus\n(DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of\nIMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia\nin 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor\nserum sodium levels with changes in fluid intake and hydration status. Adjust\nthe doses of concomitant therapies for DI/AVP deficiency as needed.\n\nADVERSE REACTIONS\n\nMost common adverse reactions (incidence ≥20% in at least 1 indication)\nincluded skin hyperpigmentation, injection site reactions, nausea, headache,\ndiarrhea, abdominal pain, vomiting, depression, and spontaneous penile\nerection.\n\nUSE IN SPECIFIC POPULATIONS\n\nTreatment with IMCIVREE is not recommended when breastfeeding. Discontinue\nIMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh\nthe potential risks to the fetus.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1\n(833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. See\nsection 4.8 of the Summary of Product Characteristics\n(https://www.globenewswire.com/Tracker?data=Y_P1X34undcs2XCYe1DVHz52Ee4OjDEog3f_ol7jWMbzrLWtb78NpOWThep60x4A4Nxq3MmFW9wyb3lYDUFRwCYX6kRteps3jBf3-O1QD7J1MxrYmbAAi553gqMgVusgM90ccdWlncUfC9i5bmYzJaoTgtLtojgklGumCiyZeAfd8zVX9pMgTBQo9pJgPSqAdiWuJqEhSl_l4te4mj5KkL_K1WT_Aw5p-Gd2Q3lUVbj6564sF6YkpF5O5rIxzx0EWuPbm5JcFVubxybdvzr4OYPCB70vS7CgeDJ8a3frtX8u5mD7e7jr0YebhkW5uWxMOwBS2ASvcbSFwTxOmxhFWhtUR2g3Gc1cCPjfi1Ukz8CdqpWxDPxAAWBzLyuFOhxAaVHOKpaDVaw1D487rZ67hC2fNMe2qpNSKRs7i1LkxPSCCkz_gTaorT13FW57ShJT6wpxYD2BetbEFdJgeo60sdV6KRHzi8alLpqSw4ALezAybnr-HJCMgOGvAI0Bptbg2WPAVwFbOoeDReTwgfqh5FmzccJKijncOj99JKXJ8lxYVaIEwk1pgowqHwvBEdBaVtBGWOo3Zk0hJdwg4C6fqUPkRYRTn9ggkcf_XrdIPrSvd4nnty3uDK8h1y2EZ12xH_EjXgUIPZFy3MXSrdUvDRC5rr_oGZXX0IsmgwmBWIX2oQLYBBh5Wmjn8_QNaPMf8CYfcZlD_jN4ezKPYNl1AHrMQVpEXd_4qp1QxvifOdOS1O7JzL3-IjhaKvCAWjhWcDnXvXxWsKZyL6UTbG6szA==)\nfor information on reporting suspected adverse reactions in Europe.\n\nPlease see the full Prescribing Information for additional Important Safety\nInformation.\n\nForward-looking Statements \n\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. All statements contained\nin this press release that do not relate to matters of historical fact should\nbe considered forward-looking statements, including, without limitation,\nstatements regarding our clinical data from clinical trials, including\npost-hoc analyses thereof, and real world data related to patients treated\nwith setmelanotide, the safety, efficacy, potential benefits of, and clinical\ndesign or progress of any of our products or product candidates at any dosage\nor in any indication; , our anticipated presentations of data at the European\nCongress of Endocrinology; including the content, date and timing of any of\nthe foregoing. Statements using words such as “expect”, “anticipate”,\n“believe”, “may”, “will” and similar terms are also\nforward-looking statements. Such statements are subject to numerous risks,\nuncertainties and other important factors, including those discussed under the\ncaption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the\nthree months ended March 31, 2026, and our other filings with the Securities\nand Exchange Commission. Except as required by law, we undertake no\nobligations to make any revisions to the forward-looking statements contained\nin this release or to update them to reflect events or circumstances occurring\nafter the date of this release, whether as a result of new information, future\ndevelopments or otherwise.\n\nCorporate Contacts: \nDavid Connolly \nHead of Investor Relations and Corporate Communications \nRhythm Pharmaceuticals, Inc. \n857-264-4280 \ndconnolly@rhythmtx.com  \n\nKate Walsh\nDirector, Corporate Communications \n857-264-4280 \nKwalsh@rhythmtx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/b767aaa5-9915-465f-9233-d97757f4e387)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3Kh1Bt","title":"Rhythm Pharmaceuticals Announces New Data Presentations at the 2026 European Congress of Endocrinology","author":"Globe Newswire","ticker":"RYTM","created":"2026-05-12T12:00:02.226Z","tickers":["RYTM"],"exchange":"NASDAQ","article_body":"– Real world data showed clinically meaningful BMI reductions with\nsetmelanotide in 62 adults with 12-month data living with acquired\nhypothalamic obesity (HO) in France –\n\n– Phase 3 analyses demonstrated improvements across multiple cardiometabolic\nrisk indices with setmelanotide in acquired HO –\n\n– New research highlights the burden and under recognition of hyperphagia\n–\n\nBOSTON, May 12, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:\nRYTM), a global commercial-stage biopharmaceutical company focused on\ntransforming the lives of patients living with rare neuroendocrine diseases,\ntoday announced that Rhythm and its collaborators will present six posters,\nincluding four featuring new data, relating to the company’s work with\nsetmelanotide at The European Congress of Endocrinology (ECE), taking place\nMay 9-12, 2026 in Prague.\n\n“Obesity due to rare neuroendocrine diseases is often accompanied by\nhyperphagia and severe metabolic complications that significantly affect\npatients’ health and daily lives,” said David Meeker, M.D., Chairman,\nChief Executive Officer and President of Rhythm Pharmaceuticals. “Real-world\ndata generated from the pre-marketing, early-access program in France show\nthat setmelanotide is associated with clinically meaningful improvements not\nonly in body weight, but also improvements across multiple cardiometabolic\nrisk measures and disease-defining features, providing a more comprehensive\npicture of the treatment impact in these diseases.”\n\nReal-World BMI Outcomes in Adult Patients with Acquired Hypothalamic Obesity\nTreated With Setmelanotide for up to 12 Months in France\n\nThis real-world analysis evaluated adults with acquired hypothalamic obesity\n(HO) treated with setmelanotide through France’s early-access program for up\nto twelve months. A total of 62 patients with acquired HO had started\nsetmelanotide therapy, as of November 30, 2025. The results showed that\npatients with acquired HO on setmelanotide achieved significant reductions in\nBMI and meaningful decreases in hunger scores. Key findings include:\n* -13.0% reduction in mean BMI from baseline (p<0.0001) in patients who\nreached 6 months (n=39);\n* -19.6% reduction in mean BMI from baseline (p<0.0001) in patients who\nreached 9 months (n=26);\n* -16.9% reduction in mean BMI from baseline (p<0.0001) in patients who\nreached 12 months (n=25)\n* The majority of patients had a BMI reduction of ≥10% after 6, 9, or 12\nmonths of treatment;\n* Patients achieved improvements in obesity classes with 18.0%, 34.6%, and\n28.0% of patients no longer living with obesity after 6, 9, and 12 months,\nrespectively;\n* Patients aged ≥12 years reported improvements in all four hunger questions\nafter 6, 9, and 12 months of treatment; and\n* No new safety concerns were observed and reported adverse events were\nconsistent with Phase 3 trial data.\nHyperphagia Severity in Adult Patients with Bardet-Biedl Syndrome –\nA Mixed-Methods Cross-Sectional Study in the United Kingdom \n\nThis study evaluated hyperphagia severity in adults with Bardet-Biedl syndrome\n(BBS) and obesity using questionnaires and expert-led interviews. Key findings\ninclude:\n* A total of 39 adults completed the questionnaire and 13 completed the\nsemi-structured, expert-led interviews;\n* Questionnaires alone classified only 7.7% of patients as having severe\nhyperphagia, whereas semi-structured, expert-led interviews classified 69.2%\nof participants as having severe hyperphagia; and\n* 92.3% of participants (12/13) classified a higher severity level by\ninterview compared with only 1 participant showing the same severity\nclassification across both methods.\nThis study suggests a high prevalence of severe hyperphagia in adult patients\nwith BBS and obesity in the UK and indicates substantial underreporting\nwith self-reported questionnaires.\n\nImpact of Setmelanotide on Metabolic Index Scores in Phase 3 Trial\nParticipants with Acquired Hypothalamic Obesity \n\nA post hoc analysis of the Phase 3 TRANSCEND trial assessed the impact of\nsetmelanotide on multiple validated cardiometabolic risk indices at Week 52.\nSetmelanotide treatment in patients with acquired HO led to significant\nimprovements in multiple metabolic index scores versus placebo. Key findings\ninclude:\n* Metabolic syndrome z-score mean change was -0.9 vs -0.2 for the placebo\ngroup (p<0.0001) (n=53 vs n=31)\n* The mean change in Lipid Accumulation Product (LAP) (n=68 vs n=36) from\nbaseline was -36.4 compared to -2.6 for the placebo group (p<0.0001);\n* The mean change in Triglyceride-Glucose Waist Circumference Index (TyG-WC)\n(n=63 vs n=35) was -138.3 vs +21.2 for the placebo group (p<0.0001);\n* The mean change in Visceral Adiposity Index (VAI) (n=67 vs n=35) was -1.5\nvs -0.4 for the placebo group (p=0.0009); and\n* The mean change in the Fatty Liver Index (FLI) (n=65 vs n=35) was -24.2 vs\n+4.4 for the placebo group (p<0.0001).\nThe findings highlight the broad metabolic benefits and strong clinically\nmeaningful efficacy of setmelanotide in this population, supporting its\npotential as a therapeutic option for patients with acquired HO.\n\nRecognising the Burden of Acquired Hypothalamic Obesity in Craniopharyngioma:\nCross-Country Insights from Lived Experiences to Support Integrated Care\nAcross All Life Stages \n\nThis study aimed to highlight the persistent and under-recognized\nhealth burden of acquired HO across life stages, drawing on the experiences\nof individuals with childhood-onset craniopharyngioma (CO-CP) from the\nNetherlands, Germany, and the UK. Findings include:\n* Key disease symptom burden for craniopharyngioma (CP) included pituitary\nhormone dysfunction (100%), thirst and fluid imbalance (87.9%), and weight\ngain (78.8%);\n* Fear of Addisonian crises (90.9%), social stigma (87.9%), and challenges at\nwork/school (87.9%) were reported as the most frequent quality of life\nchallenges associated with CP;\n* Across all three countries, many of the reported disease symptoms were\nassociated with acquired HO, such as hyperphagia, fatigue and reduced stamina,\nand weight gain; and\n* The transition from pediatric to adult care was reported as abrupt,\ninconsistent and fragmented with significant needs and gaps in adult\nfollow-up.\n* Patients with craniopharyngioma require diverse, evolving long-term support\nto address complex medical needs, with greater emphasis on managing acquired\nHO, as many reported symptoms are linked to this condition.\nAdditional Congress Presentations\nTwo encore posters will also be presented at ECE:\n* Efficacy and Safety of Setmelanotide in Acquired Hypothalamic Obesity:\nResults from a Double-Blind, Multicenter, Placebo-Controlled, Randomized Phase\n3 Trial; and\n* Genotype-Phenotype Correlation of Ophthalmic,\nRenal/Genitourinary, Neurological and Neurodevelopmental Manifestations\nin Published Cases of Bardet-Biedl Syndrome. \nThese presentations from ECE 2026 will be available following the\nconference at: https://hcp.rhythmtx.com/publications-presentations/  \n\nAbout Rhythm Pharmaceuticals \nRhythm is a commercial-stage biopharmaceutical company committed to\ntransforming the lives of patients and their families living with rare\nneuroendocrine diseases. Rhythm’s lead asset, IMCIVREE(® )(setmelanotide),\nan MC4R agonist designed to treat hyperphagia and severe obesity, is approved\nby the U.S. Food and Drug Administration (FDA) to reduce excess body weight\nand maintain reduction long term in adults and pediatric patients aged 4 years\nand older with acquired hypothalamic obesity, adult and pediatric patients 2\nyears of age and older with syndromic or monogenic obesity due to Bardet-Biedl\nsyndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including\nproprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin\nreceptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s\nMedicines & Healthcare Products Regulatory Agency (MHRA) have authorized\nsetmelanotide for the treatment of obesity and the control of hunger\nassociated with genetically confirmed BBS or genetically confirmed\nloss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR\ndeficiency in adults and children 2 years of age and above. The European\nCommission (EC) has authorized setmelanotide for the treatment of obesity and\ncontrol of hunger in patients 4 years of age and above with acquired\nhypothalamic obesity. Additionally, Rhythm is advancing a broad clinical\ndevelopment program for setmelanotide in other rare diseases, as well as\ninvestigational MC4R agonists bivamelagon and RM-718, and a preclinical suite\nof small molecules for the treatment of congenital hyperinsulinism. Rhythm’s\nheadquarters is in Boston, MA.\n\nSetmelanotide Indication \nIn the United States, setmelanotide is indicated to reduce excess body weight\nand maintain weight reduction long term in adults and pediatric patients aged\n4 years and older with acquired hypothalamic obesity, in adult and pediatric\npatients aged 2 years and older with syndromic or monogenic obesity due to\nBardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein\nconvertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR)\ndeficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1,\nor LEPR genes that are interpreted as pathogenic, likely pathogenic, or of\nuncertain significance (VUS). \nIn the European Union and the United Kingdom, setmelanotide is indicated for\nthe treatment of obesity and the control of hunger associated with genetically\nconfirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency\nor biallelic LEPR deficiency in adults and children 2 years of age and above.\nIn the European Union and the United Kingdom, setmelanotide should be\nprescribed and supervised by a physician with expertise in obesity with\nunderlying genetic etiology.\n\nPlease refer to the full Summary of Product Characteristics for a complete\nlist of indications, contraindications, warnings and precautions.\n\nLimitations of Use\n\nSetmelanotide is not indicated for the treatment of patients with the\nfollowing conditions as setmelanotide would not be expected to be effective:\n* Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1,\nor LEPR variants classified as benign or likely benign\n* Other types of obesity not related to acquired HO, BBS, or POMC, PCSK1 or\nLEPR deficiency, including obesity associated with other genetic syndromes and\ngeneral (polygenic) obesity.\nImportant Safety Information\n\nCONTRAINDICATIONS\n\nPrior serious hypersensitivity to setmelanotide or any of the excipients in\nIMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been\nreported.\n\nWARNINGS AND PRECAUTIONS\n\nDisturbance in Sexual Arousal: Spontaneous penile erections and increased\nfrequency of penile erections in males have occurred. Inform patients that\nthese events may occur and instruct patients who have an erection lasting\nlonger than 4 hours to seek emergency medical attention.\n\nDepression and Suicidal Ideation: Depression and suicidal ideation have\noccurred. Monitor patients for new onset or worsening depression or suicidal\nthoughts or behaviors. Consider discontinuing IMCIVREE if patients experience\nsuicidal thoughts or behaviors, or clinically significant or persistent\ndepression symptoms occur.\n\nHypersensitivity Reactions: Serious hypersensitivity reactions (e.g.,\nanaphylaxis) have been reported. If suspected, advise patients to promptly\nseek medical attention and discontinue IMCIVREE.\n\nSkin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New\nMelanocytic Nevi: Generalized or focal increases in skin pigmentation occurred\nin the majority of IMCIVREE-treated patients. IMCIVREE may also cause\ndevelopment of new melanocytic nevi or darkening of pre-existing nevi. Perform\na full body skin examination prior to initiation and periodically during\ntreatment to monitor pre-existing and new pigmented lesions.\n\nAcute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and\nsecondary adrenal insufficiency reported serious adverse reactions related to\nacute adrenal insufficiency in 5% of IMCIVREE-treated patients and no\nplacebo-treated patients. In patients with secondary adrenal insufficiency,\nmonitor for clinical signs of acute adrenal insufficiency.\n\nSodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus:\nPatients with acquired HO and concomitant central diabetes insipidus\n(DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of\nIMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia\nin 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor\nserum sodium levels with changes in fluid intake and hydration status. Adjust\nthe doses of concomitant therapies for DI/AVP deficiency as needed.\n\nADVERSE REACTIONS\n\nMost common adverse reactions (incidence ≥20% in at least 1 indication)\nincluded skin hyperpigmentation, injection site reactions, nausea, headache,\ndiarrhea, abdominal pain, vomiting, depression, and spontaneous penile\nerection.\n\nUSE IN SPECIFIC POPULATIONS\n\nTreatment with IMCIVREE is not recommended when breastfeeding. Discontinue\nIMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh\nthe potential risks to the fetus.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1\n(833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. See\nsection 4.8 of the Summary of Product Characteristics\n(https://www.globenewswire.com/Tracker?data=Y_P1X34undcs2XCYe1DVHz52Ee4OjDEog3f_ol7jWMbzrLWtb78NpOWThep60x4A4Nxq3MmFW9wyb3lYDUFRwCYX6kRteps3jBf3-O1QD7J1MxrYmbAAi553gqMgVusgM90ccdWlncUfC9i5bmYzJaoTgtLtojgklGumCiyZeAfd8zVX9pMgTBQo9pJgPSqAdiWuJqEhSl_l4te4mj5KkL_K1WT_Aw5p-Gd2Q3lUVbj6564sF6YkpF5O5rIxzx0EWuPbm5JcFVubxybdvzr4OYPCB70vS7CgeDJ8a3frtX8u5mD7e7jr0YebhkW5uWxMOwBS2ASvcbSFwTxOmxhFWhtUR2g3Gc1cCPjfi1Ukz8CdqpWxDPxAAWBzLyuFOhxAaVHOKpaDVaw1D487rZ67hC2fNMe2qpNSKRs7i1LkxPSCCkz_gTaorT13FW57ShJT6wpxYD2BetbEFdJgeo60sdV6KRHzi8alLpqSw4ALezAybnr-HJCMgOGvAI0Bptbg2WPAVwFbOoeDReTwgfqh5FmzccJKijncOj99JKXJ8lxYVaIEwk1pgowqHwvBEdBaVtBGWOo3Zk0hJdwg4C6fqUPkRYRTn9ggkcf_XrdIPrSvd4nnty3uDK8h1y2EZ12xH_EjXgUIPZFy3MXSrdUvDRC5rr_oGZXX0IsmgwmBWIX2oQLYBBh5Wmjn8_QNaPMf8CYfcZlD_jN4ezKPYNl1AHrMQVpEXd_4qp1QxvifOdOS1O7JzL3-IjhaKvCAWjhWcDnXvXxWsKZyL6UTbG6szA==)\nfor information on reporting suspected adverse reactions in Europe.\n\nPlease see the full Prescribing Information for additional Important Safety\nInformation.\n\nForward-looking Statements \n\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. All statements contained\nin this press release that do not relate to matters of historical fact should\nbe considered forward-looking statements, including, without limitation,\nstatements regarding our clinical data from clinical trials, including\npost-hoc analyses thereof, and real world data related to patients treated\nwith setmelanotide, the safety, efficacy, potential benefits of, and clinical\ndesign or progress of any of our products or product candidates at any dosage\nor in any indication; , our anticipated presentations of data at the European\nCongress of Endocrinology; including the content, date and timing of any of\nthe foregoing. Statements using words such as “expect”, “anticipate”,\n“believe”, “may”, “will” and similar terms are also\nforward-looking statements. Such statements are subject to numerous risks,\nuncertainties and other important factors, including those discussed under the\ncaption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the\nthree months ended March 31, 2026, and our other filings with the Securities\nand Exchange Commission. Except as required by law, we undertake no\nobligations to make any revisions to the forward-looking statements contained\nin this release or to update them to reflect events or circumstances occurring\nafter the date of this release, whether as a result of new information, future\ndevelopments or otherwise.\n\nCorporate Contacts: \nDavid Connolly \nHead of Investor Relations and Corporate Communications \nRhythm Pharmaceuticals, Inc. \n857-264-4280 \ndconnolly@rhythmtx.com  \n\nKate Walsh\nDirector, Corporate Communications \n857-264-4280 \nKwalsh@rhythmtx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/b767aaa5-9915-465f-9233-d97757f4e387)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-12T12:00:02.585678237Z","server_sent_at_ms":1778587202585},"received_at":"2026-05-12T12:00:02.698Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}