---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-123990"
form_type: "8-K"
ticker: "RYTM"
cik: "0001649904"
company_name: "RHYTHM PHARMACEUTICALS, INC."
filed_at: "2023-12-06T23:59:59+00:00"
generated_at: "2026-06-07T17:08:36.776529+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-23-123990
- form_type: 8-K
- ticker: RYTM
- cik: 0001649904
- company_name: RHYTHM PHARMACEUTICALS, INC.
- filed_at: 2023-12-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649904/000110465923123990/0001104659-23-123990-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649904/000110465923123990/tm2332304d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-123990
- JSON: https://secwatch.observer/filing/0001104659-23-123990.json
- Plain text: https://secwatch.observer/filing/0001104659-23-123990.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.