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BOSTON - Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM), currently valued at $4.14 billion and trading near its 52-week high of $69.89, will hold a conference call and webcast on Wednesday to disclose topline results from the Phase 2 trial of bivamelagon, an investigational oral melanocortin-4 receptor agonist being studied in patients with acquired hypothalamic obesity. According to InvestingPro data, the company has delivered an impressive 51.71% return over the past year.
The company will present data from the randomized, placebo-controlled portion of the trial at 8:00 a.m. ET. The study evaluated 28 patients aged 12 years and older who received either bivamelagon at three different dose levels (200 mg, 400 mg, or 600 mg) or placebo daily for 14 weeks. While the company maintains impressive gross profit margins of 89.62%, InvestingPro analysts note that profitability remains a key focus area for investors.
The primary endpoint of the trial was the change in body mass index from baseline after the treatment period. Patients may continue therapy in an open-label extension for up to 52 weeks.
Hypothalamic obesity is a rare neuroendocrine condition, consistent with Rhythm’s focus on developing treatments for rare diseases affecting metabolism and weight regulation.
The company’s lead product, IMCIVREE (setmelanotide), is already approved in the United States, European Union, and United Kingdom for treating certain genetic obesity disorders, including Bardet-Biedl syndrome and deficiencies in pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor.
Bivamelagon represents Rhythm’s efforts to expand its pipeline of MC4R agonists beyond setmelanotide. The company is also advancing another investigational MC4R agonist called RM-718 and developing treatments for congenital hyperinsulinism.
The announcement of these trial results comes as Rhythm continues to build its portfolio of treatments targeting rare metabolic disorders. For deeper insights into Rhythm Pharmaceuticals’ financial health and growth prospects, including 13 additional ProTips and comprehensive analysis, visit InvestingPro to access the full research report.
This article is based on information from a company press release.
In other recent news, Rhythm Pharmaceuticals has garnered attention with several significant developments. Leerink Partners initiated coverage on the company with an Outperform rating, highlighting Rhythm’s strategy for revenue growth through its treatments for rare genetic obesity, and set a price target of $88. Citizens JMP also reiterated a Market Outperform rating with a $84 price target, emphasizing the potential of Rhythm’s oral MC4R agonist, bivamelagon, which is expected to provide a convenient treatment option for hypothalamic obesity (HO). Jefferies maintained a Buy rating with an $80 price target, noting upcoming Phase II and Phase IB data for HO treatments as key growth prospects.
Rhythm Pharmaceuticals is advancing its pipeline with setmelanotide, a drug poised to become the first approved treatment for HO, with regulatory submissions planned for 2025. This drug has shown promising results in Phase 3 trials, including a significant reduction in BMI. Citizens JMP projects substantial sales growth for setmelanotide by 2032, while also highlighting bivamelagon’s potential to extend patent protection until 2045. Additionally, Rhythm is developing RM-718, a weekly subcutaneous MC4R agonist, with initial data expected by the end of 2025. These developments underscore Rhythm’s commitment to addressing rare neuro-endocrine diseases and expanding its market opportunities.
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