RHYTHM PHARMACEUTICALS, INC

Jefferies analyst Dennis Ding rates Rhythm Pharmaceuticals (RYTM) as Buy with an $80 target, citing an 80%-85% success chance for its Phase III hypothalamic obesity data, potentially boosting sales from $500M to $3B. Upside is seen in second-generation drugs with IP extending to the 2040s.

FDA expanded Imcivree (setmelanotide) approval to children ≥2 years with obesity due to BBS or POMC, PCSK1, or LEPR deficiencies. A 52-week trial showed BMI reductions: -33.8% (POMC), -13.1% (LEPR), -9.7% (BBS). Common adverse events included skin hyperpigmentation and injection site reactions.

Rhythm Pharmaceuticals' IMCIVREE, approved by the FDA for children as young as 2, treats rare obesity causes like Bardet-Biedl syndrome and POMC, PCSK1, LEPR deficiencies by targeting the MC4R pathway, addressing hyperphagia and early-onset obesity.

FDA expanded setmelanotide use for children with obesity. Bremelanotide showed promise in diabetic nephropathy. USPSTF advised against vitamin D and calcium for falls prevention. Cushing's syndrome patients have altered gut microbiomes. A new weight-loss injection outperformed others. Sexual-minority women reported better sexual health. Ohio State set a kidney donation record. Weight-loss drugs lead to other diagnoses. Palopegteriparatide now available in the U.S. Counterfeit GLP-1 drugs seized. Doctors advise on pausing GLP-1 drugs. WHO emphasizes obesity treatment beyond drugs. Demand for gender-affirming surgery rises.

FDA expands setmelanotide approval for rare genetic obesity to children aged 2-5, reducing BMI by 18% in VENTURE trial.

Rhythm Pharmaceuticals announces FDA approval of Imcivree for children aged 2 and above, targeting syndromic or monogenic obesity, including Bardet-Biedl syndrome and POMC/PCSK1/LEPR deficiencies. Imcivree is the first precision medicine for the MC4R pathway, showing significant weight and hunger reduction in trials.

Rhythm Pharmaceuticals announces FDA approval of IMCIVREE® (setmelanotide) for children as young as 2 years old with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or POMC, PCSK1, and LEPR deficiencies. IMCIVREE is the first precision medicine targeting MC4R pathway impairment, addressing hyperphagia and obesity in these rare conditions.

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FDA approves setmelanotide for children aged 2+ with syndromic/monogenic obesity due to Bardet-Biedl syndrome or POMC/PCSK1/LEPR deficiencies. Setmelanotide is the first precision medicine targeting the hypothalamic MC4R pathway, addressing hyperphagia and early-onset obesity. Phase 3 VENTURE trial results show safety and efficacy, with significant BMI reductions and improved hunger control.

Rhythm Pharmaceuticals' weight-loss treatment, imcivree, received expanded FDA approval for children as young as two with obesity due to Bardet-Biedl syndrome or pro-opiomelanocortin. The drug, initially approved in 2020 for ages 6 and older, shows significant and sustained weight and hunger reduction.