Celldex Therapeutics Inc. (CLDX) delivered another unprecedented clinical update for barzolvolimab (“barzo”) in CSU, further cementing the antibody’s position as the leading compound to change clinical practice in this disease of suffering, remarks John McCamant, editor of Medical Technology Stock Letter.
The company reviewed the 76-week data of barzo demonstrating incredible durability in patients off-drug for seven months. The data was presented at the EAACI conference in Glasgow on Friday. Then on Saturday, remarkable data in the same trial in the most painful symptoms of CSU – angioedema – showed that more than three quarters of patients in the study were angioedema free after one year.
Celldex Therapeutics Inc. (CLDX)
In our view, both the likelihood of Phase III success and blockbuster potential of barzo is become more evident than ever.
By most estimates, CSU alone affects between 0.5%-1% of the population. Hence, we believe the data show the very wide and widening therapeutic window of barzolvolimab. The stock is vastly undervalued by this metric alone.
In addition to the current Phase III trial in CSU, Celldex will shortly initiate a second Phase III trial in Chronic Inducible Urticaria (CindU). The company will also present follow-up results from the Phase II CindU trial in H2 2025.
Many other mast cell indications are on the way – the most near-term is EoE. Likely in late-Q3 by our estimate, Celldex will release Phase II data in Eosinophil Esophagitis – another mast cell mediated condition (likely wrongly termed).
Should that study prove successful, we believe the stock will begin to finally discount the myriad (up to 75) conditions that mast cell play a key role in – despite the fact that the Phase III trials will not read out until H2 2026. Other Phase II studies under way include atopic dermatitis and prurigo nodularis.
Recommended Action: Buy CLDX.
