Connect Biopharma Holdings Ltd CNTB
Connect Biopharma Holdings Ltd (Nasdaq: CNTB) is a respiratory drug developer. Its lead program, rademikibart, is in Phase 2 for acute exacerbations of asthma and COPD (Type 2 inflammation). Its next catalyst on record is rademikibart: FDA meeting to align on Phase 3 program (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: rademikibart — FDA meeting to align on Phase 3 program (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| rademikibart (Seabreeze STAT ASTHMA) | acute exacerbation of asthma | antibody | Phase 2 |
| rademikibart (Seabreeze STAT COPD) | acute exacerbation of COPD | antibody | Phase 2 |
| rademikibart (Seabreeze STAT IV) | IV add-on for acute exacerbation of asthma/COPD | antibody | Phase 2 |
Recent results and decisions
- Sep 30, 2026met Met primary endpoint: 81% reduction in 28-day treatment failure vs placebo (p=0.0122), with 85% fewer new moderate-severe exacerbations (p=0.030); FEV1 gain at Week 4 of 70 mL not significant (p=0.1607).
Rademikibart significantly reduced the rate of treatment failure by 81% through Week 4 compared to placebo (p=0.0122)
Filing - Sep 15, 2026mixed Primary endpoint of 28-day treatment failure not statistically significant (2.5% vs 7.4%, 66% reduction, p=0.153); key secondary Day 7 post-BD FEV1 significantly improved (+130 mL vs placebo, p=0.023).
Rademikibart reduced the treatment failure rate by approximately 66% over 28 days compared to placebo (p=0.153).
Filing - Mar 30, 2026positive Phase 1 IV rademikibart 300 mg push produced rapid FEV1 gains (many patients >=200 mL by 15 min) with mean ~200-400 mL improvements maintained through Day 29; no SAEs (n=12 asthma, 10 COPD).
Mean FEV1 improvements from baseline of ~200 - 400 mL in patients receiving rademikibart were generally maintained through Day 29 in both asthma and COPD patients, while placebo patients in both cohorts trended down
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
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Other phase 2 respiratory companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.