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BOSTON - Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM), a $4.14 billion biotech company with impressive gross profit margins of nearly 90%, reported positive results from its Phase 2 trial of bivamelagon, an investigational oral melanocortin-4 receptor agonist, for treating acquired hypothalamic obesity. According to InvestingPro data, the company’s stock is trading near its 52-week high of $69.89, reflecting strong market confidence in its clinical developments.
The 14-week, double-blind, placebo-controlled trial demonstrated statistically significant body mass index (BMI) reductions of 9.3% in the 600mg cohort and 7.7% in the 400mg cohort, compared to a 2.2% increase in the placebo group.
Patients in both the 600mg and 400mg cohorts achieved mean reductions of more than 2.8 points in their "most" hunger scores measured on a 10-point scale, while the 200mg arm showed a 2.1-point reduction. Placebo patients reported increased hunger scores.
The company indicated that bivamelagon’s BMI reductions were consistent with those achieved by setmelanotide, another MC4R agonist, in similar patient populations during past trials.
Safety results aligned with the drug’s mechanism of action, with most common adverse events being mild episodes of diarrhea and nausea. Four patients reported mild, localized hyperpigmentation, including one on placebo. One patient discontinued therapy due to a serious adverse event.
Acquired hypothalamic obesity occurs following damage to the brain’s hypothalamic region, which controls hunger and weight regulation. It most frequently follows the growth or surgical removal of certain brain tumors, and can also result from traumatic brain injury, stroke, or inflammation.
Rhythm plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration and seek scientific advice from European regulators regarding a potential Phase 3 trial design. The company is also refining the drug’s formulation to potentially improve tolerability. With a healthy current ratio of 3.3 and strong revenue growth of 49% over the last twelve months, Rhythm appears well-positioned to fund its clinical development programs.
Of the 27 patients who completed the placebo-controlled portion, 26 transitioned to the open-label extension, which is ongoing.
This information is based on a press release statement from Rhythm Pharmaceuticals. InvestingPro analysis reveals that 4 analysts have recently revised their earnings estimates upward, with a bullish consensus recommendation. Discover more insights about RYTM and access comprehensive financial analysis through the Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Rhythm Pharmaceuticals is set to announce the results of a Phase 2 trial for bivamelagon, an oral treatment for hypothalamic obesity. The trial involved 28 patients and evaluated the change in body mass index as its primary endpoint. This development is part of Rhythm’s ongoing efforts to expand its portfolio of treatments for rare metabolic disorders. Leerink Partners initiated coverage on Rhythm Pharmaceuticals with an Outperform rating, citing the company’s strategy for revenue expansion through its focus on rare genetic obesity treatments. Citizens JMP reiterated a Market Outperform rating, highlighting the potential of bivamelagon as a convenient treatment option for hypothalamic obesity. Jefferies also maintained a Buy rating, noting the significance of upcoming Phase II and Phase IB data for the company’s growth prospects. Additionally, Rhythm is advancing other investigational treatments, including RM-718, with initial data expected by the end of 2025. These developments reflect Rhythm’s strategic positioning in the field of rare obesity treatments.
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