---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-071966"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2025-05-15T23:59:59+00:00"
generated_at: "2026-05-21T05:23:06.311137+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Cabaletta Bio to file BLA for rese-cel in myositis in 2027 after FDA alignment; cash $131.8M

## Summary
- FDA aligned on two registrational cohorts for rese-cel in myositis (~15 patients each, 26-week primary endpoint); BLA submission expected in 2027.
- RMAT designation granted for rese-cel in myositis, enabling Fast Track/Breakthrough benefits and expedited BLA review.
- Cash and equivalents $131.8M at March 31, 2025, down from $164M at Dec 31, 2024; funding into first half 2026.
- FDA registrational discussions for SLE/LN anticipated in 3Q25; for systemic sclerosis in 4Q25.
- Three oral presentations of rese-cel data in myositis, SLE/LN, and systemic sclerosis at EULAR 2025 in June.

## SEC filing metadata
- accession: 0000950170-25-071966
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2025-05-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759138/000095017025071966/0000950170-25-071966-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000095017025071966/caba-20250515.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-071966
- JSON: https://secwatch.observer/filing/0000950170-25-071966.json
- Plain text: https://secwatch.observer/filing/0000950170-25-071966.txt

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