- The company now expects data from the program in the fourth quarter of 2026.
- The program spans across 43 countries and over 500 sites and will evaluate the clinical effect of barzolvolimab in reducing urticaria activity at week 12.
- The company plans to submit an application seeking approval for the therapy to the U.S. Food and Drug Administration in 2027.
Shares of Celldex (CLDX) closed 24% higher on Wednesday after the company said that it has completed enrollment in a global late-stage program of Barzolvolimab in Chronic Spontaneous Urticaria ahead of schedule and data from it is now expected in the fourth quarter 2026.
Overall, 1939 patients were enrolled in the program which includes two trials, the company said. The program spans across 43 countries and over 500 sites and will evaluate the clinical effect of barzolvolimab in reducing urticaria activity at week 12.
“Completing enrollment in these large Phase 3 CSU studies 6 months ahead of guidance highlights the significant unmet need in CSU…” said CEO Anthony S. Marucci.
Trial Goal And Design
The company plans to submit an application seeking approval for the therapy to the U.S. Food and Drug Administration in 2027 based on the data. The Phase 3 Program is designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment.
Chronic spontaneous urticaria (CSU) is a skin condition characterized by itchy wheals (hives), angioedema (swelling), or both, occurring daily or almost daily for more than six weeks without an identifiable external trigger.
As per data from the company’s mid-stage study of barzolvolimab in CSU, barzolvolimab has the potential to deliver symptom free complete control and dramatic improvements in quality of life and angioedema. Up to 51% of patients on the study had a complete response and were symptom free at 12 weeks.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around CLDX stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.
A Stocktwits user expressed optimism for the company’s market capitalization rising up to $25 billion on the strength of barzolvolimab’s annual sales. The user expects the drug’s sales to out perform Dupixent, a drug jointly developed and manufactured by Sanofi and Regeneron Pharmaceuticals, Inc.
According to data from Koyfin, the average price target on CLDX is $53.36, representing a potential upside of about 73% from current trading levels. Of the 16 analysts covering the stock, 13 rate it ‘Buy’ or higher while two rate it ‘Hold’ and one rates it a ‘Strong Sell.’
CLDX stock has risen over 48% over the past 12 months.
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