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Connect Biopharma reports strong COPD data; plans FDA-aligned Phase 3 program

Sep 30, 2026, 7:36 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Strong topline efficacy signals in COPD with a clear regulatory path to Phase 3; licensing upside with Simcere adds optionality; near-term catalysts include FDA discussions and the results call.

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Connect Biopharma announced topline Phase 2 Seabreeze STAT data for rademikibart in COPD, showing large reductions in treatment failure, exacerbations, and ED visits. The company aims to align with the FDA on a Phase 3 registrational program and hosts an investor call; successful Phase 3 progression could unlock a significant upside via continued COPD advancement and Greater China licensing with Simcere.

Phase 2 Seabreeze STAT: rademikibart cuts treatment failure 81% (p=0.0122).
Exacerbations reduced 85% through Week 4 (p=0.030).
ED visits/hospitalizations for new exacerbations reduced 100% (p=0.0137).
No new safety signals; tolerability better than placebo.
FDA Phase 3 program alignment planned; results call today at 8:00 a.m. ET.

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Connect Biopharma reports strong COPD data; plans FDA-aligned Phase 3 program

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