| Drug / Therapy | barzolvolimab |
| Indication | chronic spontaneous urticaria |
| Decision Type | PDUFA |
| Conditions | chronic spontaneous urticaria |
| Interventions | barzolvolimab |
Celldex Therapeutics (CLDX) operates in the Immuno-Oncology sector. The current BTS Score is 66 (Grade: B).
Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.
The PDUFA date for barzolvolimab by Celldex Therapeutics (CLDX) is scheduled for July 22, 2026. This is the target date for the FDA to make a decision on this application.
barzolvolimab is being developed by Celldex Therapeutics for the treatment of chronic spontaneous urticaria. It is under FDA review.
If barzolvolimab receives FDA approval, Celldex Therapeutics (CLDX) would be able to market the drug in the United States for chronic spontaneous urticaria. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for CLDX on DilutionWatch at dilutionwatch.com/stock/CLDX.html.
You can view the full BiotechSign company profile for Celldex Therapeutics (CLDX) at biotechsign.com/app/company/CLDX, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.
This page is for informational purposes only and does not constitute investment advice. FDA decision dates are subject to change. Clinical trial outcomes are inherently uncertain. Biotech stocks are highly volatile — past performance does not guarantee future results. Always consult a qualified financial advisor before making investment decisions. BiotechSign is not a registered investment advisor.