Catalyst overview
Research summary
This catalyst tracks a Approved update for IMCIVREE™ (Setmelanotide) in Acquired Hypothalamic Obesity (HO). The expected timing is based on the latest available company guidance and may change.
TRANSCEND Trial. 4/7/25- Trial met primary endpoint. 5/7/25- New data reported. Topline data from Japanese cohort in Q1 2026. 8/20/25- sNDA accepted with initial PDUFA date Dec 20, 2025. 11/7/25- Review period extended. Updated PDUFA date March 20, 2026. 02/26/26:- PDUFA on March 20, 2026; Japanese cohort topline March 2026; ObesityWeek 2025 TRANSCEND data showed significant BMI and cardiometabolic benefits. 03/01/26:- New 52-week TRANSCEND data; FDA package Mar 2; PDUFA Mar 20; CHMP opinion Q2 2026, EU decision H2 2026. 03/19/26:- FDA approved IMCIVREE for acquired HO ages ≥4. TRANSCEND Ph3 showed -18.4% placebo-adjusted BMI at 52 weeks. 05/04/26:- PES 2026 showed 2.5-year 16-week Ph2 pediatric data and 1-year TRANSCEND pediatric improvements. 05/05/26:- EC approved acquired HO; 150 U.S. patient starts; Japan PMDA H2 2026 decision, launch by year-end. 05/12/26:- France early-access showed 12-month BMI -16.9%. TRANSCEND Week 52 post hoc showed improved metabolic indices. 05/29/26:- ENDO 2026 to feature setmelanotide acquired HO Ph2 LTE 2.5-year and Ph3 bariatric surgery analyses. 06/15/26:- Phase 2/LTE showed 2.5-year BMI reduction; Phase 3 post hoc showed weight-category gains and bariatric-surgery benefits. 08/04/26:- Q2 sales $71.3M; 400 acquired HO starts; ESPE data September; Japan launch Year-End 2026; Europe 2027.
Verification
Confirm timing and program details against the company announcement or filing.