Celldex Jumps to 52-Week High on Late-Stage Trial Launch
Biotech company initiates pivotal Phase 3 study for its novel chronic hives treatment, barzolvolimab, targeting a significant unmet need.
Shares of Celldex Therapeutics Inc. (NASDAQ: CLDX) surged to a 52-week high on Tuesday after the company announced the initiation of a global, registrational Phase 3 clinical program for its key drug candidate, barzolvolimab, in treating two forms of chronic hives.
The stock climbed as much as 9.5%, touching $29.83 in morning trading, as investors welcomed the advancement of a critical asset in the company's pipeline. The move pushes Celldex’s market capitalization closer to $2 billion, reflecting growing optimism about the drug's commercial potential.
The late-stage program will evaluate the safety and efficacy of barzolvolimab in patients with Cold Urticaria (ColdU) and Symptomatic Dermographism (SD), two of the most common forms of chronic inducible urticaria. These conditions are characterized by debilitating hives and swelling triggered by cold exposure or scratching of the skin, respectively. The initiation of these pivotal trials is a crucial step toward seeking regulatory approval from the U.S. Food and Drug Administration (FDA) and other global health authorities.
"The advancement of barzolvolimab into this registrational Phase 3 program marks a significant milestone for Celldex and, more importantly, for patients who live with the often-disruptive symptoms of these chronic conditions," said Anthony Marucci, President and CEO of Celldex, in the company's official press release.
A Novel Approach to a Frustrating Condition
Barzolvolimab represents a new approach in a therapeutic area that has seen limited innovation. The drug is a monoclonal antibody that targets the KIT receptor on mast cells, which are the primary drivers of inflammatory and allergic responses. By inhibiting this pathway, barzolvolimab is designed to deplete mast cells, addressing the root cause of the urticaria.
This mechanism stands in contrast to the current standard of care. Patients are typically first treated with H1-antihistamines, but many fail to achieve adequate symptom control even at high doses. For these refractory cases, the go-to biologic is Xolair (omalizumab) from Genentech and Novartis, which targets Immunoglobulin E (IgE). While effective for many, a significant portion of patients still do not respond, leaving a substantial unmet medical need.
Symptomatic Dermographism is the most common form of physical urticaria, affecting an estimated 2% to 5% of the general population, while Cold Urticaria affects about 0.05% of people. For these individuals, daily life can be a challenge, with constant itching, painful swelling, and the avoidance of common triggers.
Crowded Field and Blockbuster Potential
Celldex is positioning barzolvolimab to capture a significant share of the global urticaria market, which is projected to reach over $11 billion by 2032. Some analysts project the drug could achieve blockbuster status, with peak annual sales exceeding $1 billion by 2030, assuming successful approvals across multiple urticaria indications.
The analyst community is broadly positive on Celldex, with 13 of 16 analysts covering the stock holding a 'Buy' or 'Strong Buy' rating, according to market data. The consensus price target sits at approximately $53, suggesting significant upside from current levels.
However, the path forward is not without competition. Beyond the established presence of Xolair, Novartis is also advancing its own oral candidate, remibrutinib, which is in Phase 3 trials for chronic spontaneous urticaria. Remibrutinib works by inhibiting Bruton's tyrosine kinase (BTK), another pathway involved in mast cell activation.
The initiation of the Phase 3 trials is a capital-intensive process, but Celldex appears well-positioned to fund its development pipeline. The company reported a strong cash position in its most recent quarterly earnings, providing a sufficient runway to see it through key clinical readouts.
With barzolvolimab now in late-stage studies for multiple types of chronic hives, Celldex is moving closer to a potential transition from a clinical-stage biotech to a commercial-stage pharmaceutical company. Investors will now be closely watching for enrollment updates and eventual top-line data from the program, which will be a pivotal catalyst for the company's future.