---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-270840"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2023-11-06T23:59:59+00:00"
generated_at: "2026-06-08T21:17:14.559854+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 fourth CABA-201 IND, now in generalized myasthenia gravis

## Summary
- FDA cleared IND for CABA-201 in generalized MG; fourth IND across autoimmune diseases.
- Phase 1/2 trial to enroll 12 patients in two parallel cohorts: AChR+ (n=6) and AChR- (n=6).
- Starting dose remains 1 x 10^6 cells/kg, consistent with lupus, myositis, and systemic sclerosis trials.
- gMG affects ~85% of an estimated 50,000-80,000 MG patients in the U.S.
- Company expects initial clinical data from lupus/myositis trials in H1 2024.

## SEC filing metadata
- accession: 0001193125-23-270840
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2023-11-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759138/000119312523270840/0001193125-23-270840-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000119312523270840/d854062d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-270840
- JSON: https://secwatch.observer/filing/0001193125-23-270840.json
- Plain text: https://secwatch.observer/filing/0001193125-23-270840.txt

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