Celldex's Barzolvolimab Hits All Endpoints in Two Phase 3 CSU Trials
CLDX sits 74% above its 52-week low of $22.1.
Summary
Celldex announced that barzolvolimab met the primary and all key secondary endpoints in both Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies for chronic spontaneous urticaria (CSU) at Week 12. The drug was well-tolerated with a favorable safety profile through 24 weeks. Treatment will continue to 52 weeks, and the company plans a BLA submission in 2027. This is a major de-risking event for the company's lead asset, with a market cap of ~$3 billion. The positive results follow the Q2 10-Q, which noted Phase 3 CSU topline data was expected; this is the first disclosure of those results. Next catalyst: 52-week data and BLA submission in 2027.
At the time of this announcement, CLDX was trading at $38.46 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3B. The 52-week trading range was $22.10 to $45.14. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.