---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-145622"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2023-05-16T23:59:59+00:00"
generated_at: "2026-06-14T23:53:45.125293+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Cabaletta Bio receives FDA clearance for second CABA-201 IND, Phase 1/2 trial in myositis

## Summary
- FDA cleared IND for CABA-201 in active idiopathic inflammatory myopathy (myositis); second IND clearance within two months.
- Phase 1/2 trial to enroll 18 patients across three subtypes: dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy.
- Initial dose 1 x 10^6 cells/kg, informed by preclinical data and Lancet Rheumatology publication.
- Myositis subtypes impact ~66,000 patients in US; current treatments often inadequate.

## SEC filing metadata
- accession: 0001193125-23-145622
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2023-05-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759138/000119312523145622/0001193125-23-145622-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000119312523145622/d505525d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-145622
- JSON: https://secwatch.observer/filing/0001193125-23-145622.json
- Plain text: https://secwatch.observer/filing/0001193125-23-145622.txt

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