RHYTHM PHARMACEUTICALS, INC

Rhythm Pharmaceuticals' setmelanotide achieved a 19.8% BMI reduction at 52 weeks in the Phase 3 TRANSCEND trial for acquired hypothalamic obesity, with 80% of patients achieving clinically meaningful weight loss.

Obesity medication prescriptions among US adolescents aged 12-17 years increased by 301.7% between 2020 and 2023, driven primarily by FDA approvals of semaglutide and phentermine-topiramate for pediatric use.

DelveInsight's 2025 pipeline report reveals a robust obesity therapeutics landscape with over 80 companies developing more than 100 pipeline drugs across various clinical stages.

Rhythm Pharmaceuticals' Imcivree (setmelanotide) demonstrated a 19.8% placebo-adjusted reduction in BMI over 52 weeks in patients with acquired hypothalamic obesity, a rare condition caused by hypothalamic damage.

Rhythm Pharmaceuticals' setmelanotide (Imcivree) demonstrated a 16.5% reduction in body weight compared to a 3.3% gain with placebo in patients with hypothalamic obesity over 52 weeks of treatment.

Rhythm Pharmaceuticals has terminated its 2021 licensing agreement with RareStone Group Ltd., reacquiring rights to IMCIVREE (setmelanotide) in mainland China, Hong Kong, and Macau for $6.3 million.

Rhythm Pharmaceuticals' setmelanotide has received orphan drug designation from Japan's Ministry of Health for the treatment of acquired hypothalamic obesity, a rare condition affecting an estimated 5,000-8,000 patients in Japan.

Rhythm Pharmaceuticals reports preliminary unaudited net revenues of approximately $42 million for Q4 2024 and $130 million for full year 2024 from global IMCIVREE® sales.

A fixed-dose combination of cagrilintide and semaglutide led to greater weight loss at 68 weeks compared to either drug alone or placebo in the REDEFINE 1 trial.

The FDA has expanded the approval of setmelanotide (Imcivree) to include children aged 2 to 5 years with rare genetic forms of obesity.