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Should Celldex’s Global Phase 3 EMBARQ Trial for Barzolvolimab in Inducible Urticaria Require Action From CLDX Investors?

Simply Wall St · 3d ago
  • Earlier this week, Celldex Therapeutics announced it has begun a global Phase 3 EMBARQ trial of barzolvolimab in adults with cold urticaria and symptomatic dermographism who remain symptomatic despite H1 antihistamines or biologics, enrolling about 240 patients across 75 sites in 7 countries.
  • This marks the second Phase 3 program for barzolvolimab and follows a prior placebo-controlled Phase 2 study where the drug achieved statistically significant improvements in provocation test responses and sustained clinical benefits through 20 weeks.
  • Next, we’ll examine how advancing barzolvolimab into global Phase 3 testing in difficult-to-treat inducible urticaria shapes Celldex’s investment narrative.

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What Is Celldex Therapeutics' Investment Narrative?

To own Celldex today, you really have to believe barzolvolimab can convert its strong Phase 2 signal in chronic urticaria into an approved, commercially meaningful franchise before the cash burn becomes too heavy. The new global Phase 3 EMBARQ trial in cold urticaria and symptomatic dermographism reinforces that story by adding a second late-stage shot on goal in difficult, underserved indications, but it does not fundamentally change the near term picture: the main catalysts still sit with outcomes from the ongoing chronic spontaneous urticaria program and future updates from this inducible urticaria study, while the biggest risk remains sustained losses (US$177.44 million in the first nine months of 2025) without a clear path to profitability. The recent share price strength suggests the market sees the Phase 3 start as positive, but execution risk and trial timelines are still very real.

However, there is a key risk around how long Celldex can fund multiple Phase 3 programs without revenue. The valuation report we've compiled suggests that Celldex Therapeutics' current price could be inflated.

Exploring Other Perspectives

CLDX 1-Year Stock Price Chart
CLDX 1-Year Stock Price Chart
Investors in the Simply Wall St Community currently anchor around a single fair value view near US$53, underlining how much opinions can cluster before new data arrives. Against that, the costly move into another Phase 3 program and ongoing losses above US$200 million a year keep execution and funding front and center for Celldex’s future performance.

Explore another fair value estimate on Celldex Therapeutics - why the stock might be worth as much as 89% more than the current price!

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.