Chronic spontaneous urticaria
CLDXCelldex Therapeutics, Inc.Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Barzolvolimab (CDX-0159) (KIT receptor) in Chronic spontaneous urticaria. The expected timing is based on the latest available company guidance and may change.
EMBARQ-CSU1 & EMBARQ-CSU 2. 7/16/24- Initiated global Ph3.11/10/25:- Ph2 CSU study complete. 2/23/26:- Study data on prolonged off-treatment efficacy to be presented at AAAAI 2026 on Feb. 27, 2026. 2/25/26:- Enrollment completed 6 months early; topline results expected Q4 2026; BLA submission planned 2027. 02/27/26:- AAAAI: Ph2 CSU off-treatment efficacy durable to Week 76; Ph3 EMBARQ-CSU1/2 enrollment completed. 03/27/26:- AAD 2026 Ph2 CSU QoL data showed durable off-treatment benefit; EMBARQ-CSU1/2 topline expected Q4 2026. 05/07/26:- EMBARQ-CSU1/2 enrollment finished six months early; 1,939 patients; topline Ph3 CSU data Q4 2026; BLA 2027. 06/14/26:- Week 76 Phase 2 CSU angioedema results positive; Phase 3 topline still expected Q4 2026. BLA planned 2027. 07/21/26:- Phase 3 EMBARQ-CSU1/2 topline expected September/October 2026; BLA submission planned 2027 reiterated. 08/06/26:- Ph3 EMBARQ-CSU1/2 topline expected September/October 2026; BLA planned 2027.
Verification
Confirm timing and program details against the company announcement or filing.