---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-004507"
form_type: "8-K"
ticker: "RYTM"
cik: "0001649904"
company_name: "RHYTHM PHARMACEUTICALS, INC."
filed_at: "2025-04-07T23:59:59+00:00"
generated_at: "2026-05-23T19:44:47.279599+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Rhythm Pharma Phase 3 TRANSCEND trial meets primary endpoint with -19.8% placebo-adjusted BMI reduction in 120 patients

## Summary
- Mean BMI change of -16.5% on setmelanotide vs +3.3% for placebo at 52 weeks (p<0.0001); 80% achieved ≥5% BMI reduction.
- Regulatory submissions in US and EU planned for Q3 2025; setmelanotide could become first approved therapy for acquired hypothalamic obesity.
- Cash and short-term investments expected to fund operations into 2027.
- No new safety signals; most common AEs were nausea, vomiting, diarrhea, injection site reaction, skin hyperpigmentation, headache.
- Secondary endpoints: 83% of patients achieved ≥5% BMI or ≥0.2 BMI Z-score reduction; hunger score improved (p=0.003).

## SEC filing metadata
- accession: 0001558370-25-004507
- form_type: 8-K
- ticker: RYTM
- cik: 0001649904
- company_name: RHYTHM PHARMACEUTICALS, INC.
- filed_at: 2025-04-07T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649904/000155837025004507/0001558370-25-004507-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649904/000155837025004507/rytm-20250407x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-004507
- JSON: https://secwatch.observer/filing/0001558370-25-004507.json
- Plain text: https://secwatch.observer/filing/0001558370-25-004507.txt

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