Rhythm Pharma reports positive Phase 3 setmelanotide data in young children; files for EU approval

RHYTHM PHARMACEUTICALS, INC.

Phase 3 pediatrics trial: 83.3% (10/12) achieved BMI-Z score reduction ≥0.2 at 52 weeks; mean BMI reduction 18.4%.
Submitted Type II variation to EMA for setmelanotide in children 2 to <6 with BBS/POMC/PCSK1/LEPR deficiency; sNDA to FDA planned H1 2024.
Phase 2 DAYBREAK trial: response rates by genotype ranged 25%–56.3%; 49 patients randomized into Stage 2 placebo-controlled withdrawal; data expected H2 2024.
IND submitted for RM-718 (weekly MC4R agonist); Phase 1 trials including hypothalamic obesity planned H1 2024.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.