Celldex Therapeutics Announces Phase 3 Trial Results for Barzolvolimab

What Happened
Celldex Therapeutics, Inc. (CLDX) filed an 8-K on September 22, 2026, reporting that it issued a press release announcing results from its two Phase 3 trials—EMBARQ‑CSU1 and EMBARQ‑CSU2—evaluating Barzolvolimab in chronic spontaneous urticaria (CSU). The press release is included as Exhibit 99.1 to the filing.

Key Details

• Filing date: September 22, 2026 (Form 8‑K, Item 8.01 — Other Events).
• Trials named: EMBARQ‑CSU1 and EMBARQ‑CSU2 (both Phase 3, indication: chronic spontaneous urticaria).
• Investigational therapy: Barzolvolimab.
• Press release attached to the 8‑K as Exhibit 99.1 and incorporated by reference.

Why It Matters
Phase 3 trial readouts are material clinical milestones that can affect a biotech company’s regulatory path, near‑term development plans, and investor expectations. By publicly disclosing the EMBARQ‑CSU1 and EMBARQ‑CSU2 results in a press release and filing the 8‑K, Celldex has made information available that investors can use to reassess the company’s clinical progress and potential value related to Barzolvolimab in CSU.