Catalyst overview
Research summary
This catalyst tracks a Phase 3 update for Barzolvolimab (CDX-0159) in Chronic inducible urticaria. The expected timing is based on the latest available company guidance and may change.
7/29/24- Reported topline results. 10/28/24- Met all primary & secondary endpoints. 3/1/25- Presented Ph2 data at AAAAI'25. 11/6/25- New data presented at ACAAI'25. Initiate Ph3 trial in ColdU and SD in December 2025. 11/10/25:- 20-week Ph2 ColdU/SD data positive; OLE data expected Q1 2026; Ph3 initiation planned December 2025. 12/09/25:- Global Phase 3 EMBARQ-ColdU and SD initiated; Phase 2 OLE data expected Q1 2026. 02/23/26:- Phase 2 ColdU/SD study and OLE data to be presented at AAAAI 2026, including late-breaking OLE results. 02/25/26:- Ph3 EMBARQ-ColdU/SD enrollment actively accruing; late-breaking ColdU/SD Ph2 data to be presented March 1, 2026. 03/01/26:- Ph2 ColdU/SD OLE retreatment data positive at AAAAI 2026; Ph3 EMBARQ-ColdU/SD enrolling. 03/27/26:- AAD 2026 posters showed Ph2 ColdU/SD QoL improvements; Ph3 EMBARQ-ColdU/SD enrollment ongoing. 05/07/26:- EMBARQ-ColdU/SD Ph3 trial actively enrolling; prior positive Ph2 efficacy and QoL data reiterated. 07/21/26:- Phase 3 EMBARQ-ColdU/SD enrollment on track; data timing not provided. 08/06/26:- Ph3 EMBARQ-ColdU/SD actively enrolling; no data timing provided.
Verification
Confirm timing and program details against the company announcement or filing.