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

Simply Wall St.

Dec 11, 2025

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...

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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. We've found 12 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free.AdvertisementWhat 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.  \nThe valuation report we've compiled suggests that Celldex Therapeutics' current price could be inflated.Exploring Other PerspectivesCLDX 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!Build Your Own Celldex Therapeutics NarrativeDisagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.A great starting point for your Celldex Therapeutics research is our analysis highlighting 1 key reward and 2 important warning signs that could impact your investment decision.Our free Celldex Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Celldex Therapeutics' overall financial health at a glance.Want Some Alternatives?Every day counts. These free picks are already gaining attention. See them before the crowd does:This technology could replace computers: discover 28 stocks that are working to make quantum computing a reality.Rare earth metals are an input to most high-tech devices, military and defence systems and electric vehicles. The global race is on to secure supply of these critical minerals. Beat the pack to uncover the 37 best rare earth metal stocks of the very few that mine this essential strategic resource.Uncover the next big thing with financially sound penny stocks that balance risk and reward.  This article by Simply Wall St is general in nature. We provide commentary based on historical data\n    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\n    financial situation. We aim to bring you long-term focused analysis driven by fundamental data.\n    Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.\n    Simply Wall St has no position in any stocks mentioned.New: AI Stock Screener & AlertsOur new AI Stock Screener scans the market every day to uncover opportunities.• Dividend Powerhouses (3%+ Yield)• Undervalued Small Caps with Insider Buying• High growth Tech and AI CompaniesOr build your own from over 50 metrics.Explore Now for FreeHave feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}