Celldex Expands Into Asthma: Early CDX-622 Trial Signals New Growth Angle for CLDX

Celldex Therapeutics (CLDX) announced an update on their ongoing clinical study.

Study Overview: Celldex Therapeutics is launching a Phase 1 study called “An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma.” The goal is to see how safe the new drug CDX-622 is, how it behaves in the body, and how it may affect asthma in adults with mild to moderate disease. For investors, this is an early but important step that could expand Celldex’s pipeline into the large asthma market if results are supportive.

Intervention/Treatment: The study tests CDX-622, an experimental drug given through an IV infusion. It is designed to help manage asthma by targeting pathways involved in inflammation and breathing problems. The trial uses a single dose to build a first safety and dosing profile before any larger studies.

Study Design: This is an interventional trial with a single treatment group. All enrolled participants receive CDX-622; there is no placebo or comparison arm. The study is open-label, which means both doctors and participants know they are getting the drug. The main purpose is treatment-focused safety testing, typical for an early-stage asthma program.

Study Timeline: The study was first submitted on September 26, 2025, signaling the formal start of the clinical path for CDX-622 in asthma. It is currently listed as “Not yet recruiting,” so enrollment has not begun. The latest update was filed on January 20, 2026, showing the record is active and recently reviewed. Primary completion and overall completion dates have not yet been posted, which is common at this early stage.

Market Implications: For Celldex (CLDX), this new study marks a move into asthma, a large and competitive space dominated by players like AstraZeneca, GSK, and Regeneron/Sanofi. Even though this is an early Phase 1 trial, it can lift sentiment by signaling pipeline expansion beyond oncology and other immune targets. Near term, the impact on revenue is minimal, but the update supports a longer-term growth story if the drug later shows clear benefits and manageable safety. Investors may view the trial as optional upside: success could re-rate CLDX on future asthma sales potential, while early-stage setbacks are less likely to affect the core business. The study record confirms the program is active and progressing in line with a high-risk, high-reward early development profile.

The study is ongoing in its startup phase, with the latest information available on the ClinicalTrials.gov portal under NCT07330778.

To learn more about CLDX’s potential, visit the Celldex Therapeutics drug pipeline page.