{"id":918468,"date":"2025-12-10T16:04:04","date_gmt":"2025-12-10T21:04:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/rhythm-pharmaceuticals-to-announce-preliminary-data-from-exploratory-phase-2-trial-evaluating-setmelanotide-in-prader-willi-syndrome\/"},"modified":"2025-12-10T16:04:04","modified_gmt":"2025-12-10T21:04:04","slug":"rhythm-pharmaceuticals-to-announce-preliminary-data-from-exploratory-phase-2-trial-evaluating-setmelanotide-in-prader-willi-syndrome","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/rhythm-pharmaceuticals-to-announce-preliminary-data-from-exploratory-phase-2-trial-evaluating-setmelanotide-in-prader-willi-syndrome\/","title":{"rendered":"Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome"},"content":{"rendered":"
\n

BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).<\/p>\n

\n Conference Call Information<\/strong>\n <\/p>\n

Rhythm Pharmaceuticals\u00a0will host a live conference call and webcast at\u00a08:00 a.m. ET\u00a0on Thursday, December 11 to discuss this update. Participants may register for the conference call\u00a0here<\/a>. It is recommended that participants join the call ten minutes prior to the scheduled start.<\/p>\n

A webcast of the call will also be available under “Events and Presentations” in the Investor Relations section of the\u00a0Rhythm Pharmaceuticals\u00a0website at\u00a0https:\/\/ir.rhythmtx.com\/<\/a>. The archived webcast will be available on Rhythm Pharmaceuticals\u2019 website approximately two hours after the conference call and will be available for 30 days following the call.<\/p>\n

\n About\u00a0Rhythm Pharmaceuticals<\/strong>
\n
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm\u2019s lead asset, IMCIVREE\u00ae (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the\u00a0U.S. Food and Drug Administration\u00a0(FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin\/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the\u00a0European Commission\u00a0(EC) and the UK\u2019s\u00a0Medicines & Healthcare Products Regulatory Agency\u00a0(MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and\u00a0RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm\u2019s headquarters is in\u00a0Boston, MA.<\/p>\n

\n Setmelanotide Indication<\/strong>
\n
In\u00a0the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS), POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).<\/p>\n

In the\u00a0European Union\u00a0and the\u00a0United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In\u00a0Europe, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.<\/p>\n

\n Limitations of Use<\/strong>
\n
Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:<\/p>\n