Rhythm Pharmaceuticals Highlights Four Data Presentations at ObesityWeek® 2025

Rhythm Pharmaceuticals (NASDAQ: RYTM), Inc., a global biopharmaceutical company dedicated to improving the lives of patients with rare neuroendocrine diseases, announced the presentation of four datasets at ObesityWeek® 2025 in Atlanta, GA. These presentations showcased the potential of setmelanotide, the company’s lead asset, in addressing acquired hypothalamic obesity and other rare conditions.  “Acquired hypothalamic obesity is a complex and severe condition that significantly impacts patients’ lives, affecting weight, hunger, and daily functioning,” said Dr. Christian Roth of Seattle Children’s Research Institute. “Setmelanotide has demonstrated robust BMI reductions and meaningful improvements in cardiometabolic health and patient-reported outcomes, offering hope for patients where other treatments have fallen short.”

Q3 2025 Earnings Summary:

• EPS: -$0.82 (missed by $0.09)
• Revenue: $51.30M (+54.28% Y/Y, beat by $590.07K)

Key Findings from the Phase 3 TRANSCEND Trial:

• BMI Reduction with GLP-1 Therapy:
  • Patients treated with setmelanotide and GLP-1 therapy showed a 27.1% mean placebo-adjusted BMI reduction (p<0.0001).
  • Patients on setmelanotide alone achieved a 19.0% mean placebo-adjusted BMI reduction (p<0.0001).
• Patient and Caregiver Feedback:
  • Interviews with trial participants and caregivers revealed significant improvements in hunger, weight, energy, and physical activity.

Additional Presentations:

Cardiometabolic Improvements:

Dr. Jennifer Miller (University of Florida) presented data showing significant improvements in blood pressure, lipid levels, and other cardiometabolic parameters with setmelanotide treatment.

Dr. Roohi Kharofa (Cincinnati Children’s Hospital) shared findings on hyperphagia and genetic variants in early-onset obesity, based on data from 212 participants across three Pediatric Obesity Weight Evaluation Registry (POWER) sites.

Setmelanotide Indications and Limitations:

Indications: Approved for reducing excess body weight and maintaining weight reduction in patients aged 2+ with specific genetic conditions.

Limitations: Not effective for general obesity or conditions unrelated to POMC, PCSK1, LEPR deficiencies, or BBS.

Safety Information:

Common Adverse Reactions: Skin hyperpigmentation, injection site reactions, nausea, headache, and depression.

Warnings: Includes risks of skin hyperpigmentation, sexual arousal disturbances, depression, and hypersensitivity reactions.

Pediatric Use: Growth and maturation should be monitored in children.

For full prescribing information, visit Rhythm Pharmaceuticals’ website or consult the U.S. Prescribing Information and EU Summary of Product Characteristics.

Contact Information:
To report adverse reactions, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088.

About Rhythm Pharmaceuticals:
Rhythm Pharmaceuticals is committed to transforming the lives of patients with rare neuroendocrine diseases. Its lead product, IMCIVREE® (setmelanotide), is an MC4R agonist approved by the FDA, European Commission, and UK’s MHRA for treating syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed POMC, PCSK1, or LEPR deficiencies.

For more details on Rhythm’s presentations at ObesityWeek® 2025, visit: hcp.rhythmtx.com/publications-presentations.