Celldex Therapeutics Targets 2027 Filing for Barzolvolimab After Phase 3 Results

Key Points

• Celldex plans to file for approval of barzolvolimab in 2027, based on full 52-week Phase 3 data for chronic spontaneous urticaria. The company expects to present additional 24-week efficacy results in February 2027.
• In Phase 3, a majority of patients achieved complete responses, including those whose disease was refractory to omalizumab. Common adverse events were mostly mild to moderate; two probable anaphylaxis cases followed barzolvolimab dosing.
• Celldex reported $650 million in cash as of the third quarter, which it expects to fund operations through 2028 and into a potential launch. It is building commercial capabilities and plans to offer dosing every four or eight weeks if approved.

Celldex Therapeutics NASDAQ: CLDX plans to submit a biologics license application for barzolvolimab in 2027, using full 52-week data from its Phase 3 studies in chronic spontaneous urticaria, executives said at Guggenheim’s 3rd Annual Healthcare Innovation Conference.

The company expects to present a fuller look at 24-week efficacy data in February 2027 and is preparing for a potential launch with $650 million in cash as of the third quarter, according to Senior Vice President of Corporate Affairs Sarah Cavanaugh.

Phase 3 Results and Safety

Chief Medical Officer Diane Young said the Phase 3 EMBARQ studies showed complete responses in a majority of patients and clearing of angioedema, or swelling, at 12 weeks. Patients whose disease was refractory to omalizumab responded as well as the overall study population, she said.

Celldex expects data on the omalizumab-refractory subgroup to appear in the drug’s label in some form, though its placement would need to be negotiated with the Food and Drug Administration, Young said.

Chief Commercialization Officer Teri Lawver said Celldex intends to offer dosing every four or eight weeks if the drug is approved. The eight-week regimen would require seven dosing days a year, she said.

On safety, Young said the most common adverse events were KIT-mediated, mostly mild to moderate and expected to be reversible. Rates of serious adverse events and grade 3 and 4 adverse events were the same in the placebo and barzolvolimab groups, she said.

Two cases of probable anaphylaxis occurred after a first dose of barzolvolimab in the Phase 3 study, Young said. Another case adjudicated as anaphylaxis occurred after a placebo dose. She said the two probable cases were the only such cases adjudicated across the company’s subcutaneous program, which included 2,400 patients.

Young said a grade 4 classification discussed after the initial data release was an investigator attribution, not a rating by the anaphylaxis adjudication committee. Under the scale used by investigators, an emergency room visit or hospitalization was classified as grade 4, she said.

Upcoming Data and Commercial Plans

Cavanaugh said the February 2027 presentation at AAAAI will focus on efficacy, including secondary measures. Young said it will provide more detail on primary and key secondary endpoints through 24 weeks; she does not expect new safety findings from that period.

In a Phase 2 study, 41% of patients still had a complete response seven months after their last dose, Young said. The company expects to assess off-therapy durability in Phase 3, but patients must first complete 52 weeks of treatment and enter follow-up.

Lawver said Celldex sees potential demand among first-line advanced-therapy patients with severe disease or angioedema, as well as patients whose symptoms persist after another advanced therapy. The company plans to pursue a premium, value-based price and is expanding medical, analytics, brand and payer teams ahead of potential commercialization.

Other Programs and Funding

Young said Phase 3 studies of barzolvolimab in chronic inducible urticaria are enrolling, with further guidance expected in the coming months. The company also expects atopic dermatitis data by the end of the year. Young said Celldex wants the drug to perform at least as well as existing therapies in that condition and will also examine whether particular patient subsets benefit.

For CDX-622, a bispecific candidate targeting stem cell factor and TSLP, Young said a proof-of-mechanism study in asthma is intended primarily to assess the TSLP component and learn more about the molecule. Asthma and food allergy are among potential future indications, she said.

Cavanaugh said Celldex’s third-quarter cash balance is expected to fund the company through 2028 and into an initial launch.

About Celldex Therapeutics (NASDAQ:CLDX)

Celldex Therapeutics, Inc is a clinical-stage biopharmaceutical company that develops antibody-based treatments for inflammatory diseases and cancer. Its research focuses on targets involved in immune responses and the activity of mast cells.

The company's lead candidate, barzolvolimab, is an antibody that targets the KIT receptor. Celldex is studying it for chronic urticaria and other conditions associated with mast-cell activity.

Celldex also has early-stage oncology programs that investigate antibody therapies designed to affect immune pathways.

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