Rhythm Pharmaceuticals Inc

Japan’s Ministry of Health, Labour and Welfare has approved Imcivree (setmelanotid) from Rhythm Pharmaceuticals for the treatment of acquired hypothalamic obesity, the first approved therapy for this form in Japan. Rhythm estimates the patient population in Japan at 5,000–8,000 and plans to launch the product before the end of 2026, depending on pricing. The approval is based on the phase‑3 TRANSCEND study, which showed a placebo‑adjusted BMI reduction of 18.8%; Imcivree is already approved in the US and the EU. » More on de.investing.com

Rhythm reports that the US launch of IMCIVREE for acquired hypothalamic obesity is showing strong early demand, with more than 400 therapy requests in 14 weeks and prescriptions from over 300 physicians. About two-thirds of requests were approved by quarter-end; coverage policies account for roughly 25% of commercially insured and 35% of Medicaid beneficiaries. The company holds about $330 million in cash, sufficient for roughly 24 months, and does not see a near-term need for an equity raise. Rhythm is also advancing a pipeline of MC4R agonists, plans Phase III strategies for Prader-Willi before the end of 2025, and intends to further develop bivamelagon and other programs globally. » More on de.investing.com

Rhythm Pharmaceuticals reports preliminary Phase 2 results for the once‑weekly MC4R agonist RM‑718 in 11 patients with acquired hypothalamic obesity. Seven patients who completed 16 weeks showed an average BMI reduction of 11.6%, stronger than comparator values for bremelanotide (bivamelagon) (10.1% after 14 weeks) and setmelanotide (10.1% after 16 weeks). There were two mild cases of local hyperpigmentation at the injection site and common adverse events such as injection‑site reactions, nausea and vomiting; two patients discontinued due to adverse events. RM‑718 is designed for high selectivity with sparing of MC1R to reduce hyperpigmentation. Rhythm will hold a conference call on Q2 financial results. » More on de.investing.com