---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-072048"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2024-03-20T23:59:59+00:00"
generated_at: "2026-06-04T11:50:18.418808+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Cabaletta Bio receives FDA Orphan Drug Designation for CABA-201 in systemic sclerosis

## Summary
- FDA grants Orphan Drug Designation to CABA-201 for systemic sclerosis, a rare autoimmune disease.
- CABA-201 is a fully human CD19-CAR T cell therapy being studied in Phase 1/2 RESET-SSc trial.
- ODD provides tax credits, waived user fees, and potential 7-year marketing exclusivity upon approval.
- Systemic sclerosis affects <200,000 US patients; average survival ~12 years after diagnosis.

## SEC filing metadata
- accession: 0001193125-24-072048
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2024-03-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759138/000119312524072048/0001193125-24-072048-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000119312524072048/d812029d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-072048
- JSON: https://secwatch.observer/filing/0001193125-24-072048.json
- Plain text: https://secwatch.observer/filing/0001193125-24-072048.txt

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