---
schema_version: "secwatch.filing_event.v1"
accession: "0001835268-25-000019"
form_type: "8-K"
ticker: "CNTB"
cik: "0001835268"
company_name: "Connect Biopharma Holdings Ltd"
filed_at: "2025-04-01T23:59:59+00:00"
generated_at: "2026-05-24T01:05:44.996486+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Connect Biopharma gains FDA alignment for Phase 2 trials of rademikibart in acute asthma/COPD

## Summary
- FDA Type C meeting positive; agency aligned on parallel Phase 2 trials for rademikibart in acute exacerbations of asthma or COPD.
- Two placebo-controlled trials each enrolling ~160 patients with eosinophils ≥300 cells/µL; single 600 mg SC dose over 28 days.
- Initiation planned in Q2 2025; data expected in first half of 2026; cash runway into 2027.
- CEO cites prior Phase 2 maintenance data showing rapid lung function improvement within 24 hours of 600 mg dose.
- Unmet need highlighted: ~45% of patients on standard of care experience treatment failure within 28 days post-exacerbation.

## SEC filing metadata
- accession: 0001835268-25-000019
- form_type: 8-K
- ticker: CNTB
- cik: 0001835268
- company_name: Connect Biopharma Holdings Ltd
- filed_at: 2025-04-01T23:59:59+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/1835268/000183526825000019/0001835268-25-000019-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835268/000183526825000019/cntb-20250401.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001835268-25-000019
- JSON: https://secwatch.observer/filing/0001835268-25-000019.json
- Plain text: https://secwatch.observer/filing/0001835268-25-000019.txt

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