Rhythm Pharmaceuticals Inc

Rhythm Pharmaceuticals said at the Wells Fargo conference that the launch of IMCIVREE for hypothalamic obesity is in the “second quarter” of rollout and that there are already about 400 prescriptions from roughly 300 physicians. The company sees hypothalamic obesity (HO), Bardet‑Biedl syndrome and Prader‑Willi syndrome as strategic growth areas and reported positive Phase II data in Prader‑Willi that support Phase III planning. Rhythm stressed it is well capitalized and does not need to raise funds in the near term, but cited access to endocrinologists and the need for multiple studies in Prader‑Willi as operational challenges. The company is also developing follow‑on programs (RM‑718, Bivamelagon) to strengthen the pipeline and long‑term competitive position. » Mere på de.investing.com

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. » Mere på 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. » Mere på de.investing.com