Incyte Shares Rise on Positive Phase 3b Data for Eczema Cream Opzelura
The study met all primary endpoints, showing significant improvement in moderate atopic dermatitis and paving the way for a European regulatory submission.
Shares of Incyte Corporation (NASDAQ: INCY) climbed in Tuesday trading after the biopharmaceutical company announced positive topline results from a late-stage trial of its key dermatology product, Opzelura cream, in adults with moderate atopic dermatitis.
The stock rose as much as 2.2% to $91.28, trading near its 52-week high, as investors reacted to data showing the treatment met all its primary goals in the Phase 3b TRuE-AD4 study.
According to the company's official announcement, the trial demonstrated that 70.0% of patients treated with Opzelura achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75) by the eighth week. This was a stark contrast to the 18.5% of patients who saw similar improvement using a vehicle, or non-medicated cream, meeting the endpoint with high statistical significance (P<0.0001).
The study also met its other co-primary endpoint, with 61.3% of Opzelura patients achieving Investigator's Global Assessment Treatment Success (IGA-TS)—defined as clear or almost clear skin—compared to just 13.6% in the vehicle group.
Opzelura, a topical JAK inhibitor, is a critical growth driver for Incyte. The drug generated $164 million in the second quarter of 2025, a 35% increase year-over-year. The positive results from the TRuE-AD4 study are pivotal for its expansion, particularly in Europe.
“These data will support the filing of a Type-II variation application for ruxolitinib cream 1.5% (Opzelura) in Europe, as we seek to meet the needs of more patients around the world,” said Jim Lee, M.D., Group Vice President of Inflammation & Autoimmunity at Incyte. The company expects to submit the application to the European Medicines Agency (EMA) by the end of the year.
The trial enrolled 241 adults whose condition was not adequately controlled by topical corticosteroids or calcineurin inhibitors, representing a patient population with significant unmet needs. Beyond the primary goals, Opzelura also showed a rapid and substantial reduction in itch, a primary symptom of atopic dermatitis. By week eight, 62.5% of patients achieved a significant reduction in itch, compared to 19.8% with the vehicle.
The atopic dermatitis market is a competitive space dominated by systemic therapies like Sanofi and Regeneron's blockbuster drug Dupixent. However, Incyte is carving out a significant niche with Opzelura as a topical treatment. Its strong safety and efficacy profile, especially in patients who have failed other topical options, positions it as a valuable non-steroidal alternative before patients move to more potent systemic drugs.
Analyst sentiment for Incyte has been generally positive, with a consensus rating of 'Moderate Buy'. Following the data release, the company's stock price pushed above the average analyst price target of approximately $85, signaling strong investor confidence in Opzelura's growth trajectory. The drug is also approved for vitiligo, further broadening its commercial potential.
“AD is a challenging, chronic condition and I believe that these data reinforce Opzelura as an important therapeutic option,” commented Dr. Andreas Wollenberg, Professor of Dermatology and Allergy at Augsburg University Hospital in Germany and a study investigator. As Incyte prepares its European submission, investors will be closely watching for regulatory milestones that could unlock the next phase of growth for this increasingly important asset.