---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-009819"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2026-01-12T23:59:59+00:00"
generated_at: "2026-05-16T10:54:47.969094+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Cabaletta announces 2026 priorities: myositis trial enrolling, BLA 2027, Cellares IND cleared

## Summary
- Myositis registrational cohort actively enrolling; BLA submission for rese-cel projected in 2027.
- FDA aligned on registrational cohort designs in SLE and LN, each ~25 patients with unique endpoints.
- FDA granted RMAT designation for rese-cel in systemic sclerosis; registrational alignment expected 1H26.
- IND amendment cleared for Cellares automated manufacturing; clinical manufacturing data due 1H26.
- No-preconditioning dose-escalation in PV ongoing; Phase 1/2 data from 3 trials expected 1H26.

## SEC filing metadata
- accession: 0001193125-26-009819
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2026-01-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- 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/1759138/000119312526009819/0001193125-26-009819-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000119312526009819/caba-20260112.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-009819
- JSON: https://secwatch.observer/filing/0001193125-26-009819.json
- Plain text: https://secwatch.observer/filing/0001193125-26-009819.txt

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