---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-108154"
form_type: "8-K"
ticker: "RYTM"
cik: "0001649904"
company_name: "RHYTHM PHARMACEUTICALS, INC."
filed_at: "2025-11-07T23:59:59+00:00"
generated_at: "2026-05-16T23:05:15.762114+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA extends review of Rhythm's setmelanotide sNDA to March 20, 2026

## Summary
- New PDUFA goal date March 20, 2026, extended 3 months from December 20, 2025.
- FDA requested additional sensitivity analyses of Phase 3 efficacy data; no new data required.
- Major amendment classified; no safety or manufacturing issues included in the extension.
- Company expresses confidence in data and continues preparations for potential launch.

## SEC filing metadata
- accession: 0001104659-25-108154
- form_type: 8-K
- ticker: RYTM
- cik: 0001649904
- company_name: RHYTHM PHARMACEUTICALS, INC.
- filed_at: 2025-11-07T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649904/000110465925108154/0001104659-25-108154-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649904/000110465925108154/rytm-20251106x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-108154
- JSON: https://secwatch.observer/filing/0001104659-25-108154.json
- Plain text: https://secwatch.observer/filing/0001104659-25-108154.txt

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