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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

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.

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.

Market

fact

No approved product carries Chronic Inducible Urticaria on label.

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).

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.

Pipeline

fact

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

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.