Celldex Therapeutics Inc (CLDX)

Chronic Inducible Urticaria · registered primary completion 2026-10-01 · NCT06455202

Published 2026-09-02Market cap $3,072M6 sourced statements

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) · PHASE3 · n=976 · active not recruiting

Market

fact

No approved product carries Chronic Inducible Urticaria on label.

Source: FDA label index

Trial registry

fact

Registered design for NCT06455202: randomized, quadruple-masked, 976 participants (actual). Primary outcome: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score).

Source: ClinicalTrials.gov record

Runway

fact

Cash of $718M against operating outflow of $76M per quarter gives roughly 9.5 quarters of runway, clearing the registered primary completion 0.4 quarters out by 9.1 quarters.

Source: 10-Q filed 2026-08-06

Share count and dilution

fact

78,529,532 shares outstanding against 89,960,258 if every outstanding option, warrant and convertible were exercised. In that case 12.7% of a gain in enterprise value would accrue to those holders rather than to current shareholders.

Source: antidilutive-securities disclosure, 10-Q filed 2026-08-06

Regulatory

fact

Designations disclosed: Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review Voucher. These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.

Source: 10-Q filed 2026-08-06

Pipeline

fact

2 distinct molecules in 7 active company-sponsored trials; barzolvolimab accounts for 6 of them at Phase 2/Phase 3.

Source: ClinicalTrials.gov, company as lead sponsor

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This sheet is dated and will not be edited. When the registered primary completion passes, its outcome is recorded on the scoreboard and a new dated sheet is published if the filings change materially.