Kymera Therapeutics Receives FDA Fast Track Designation For KT-621, Its First-In-Class Oral STAT6 Degrader For Moderate To Severe Atopic Dermatitis

Kymera Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a new class of oral small-molecule degrader medicines for immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-621. KT-621 is Kymera’s first-in-class oral STAT6 degrader being developed for the treatment of moderate to severe atopic dermatitis (AD).

According to Nello Mainolfi, PhD, Founder, President and CEO of Kymera Therapeutics, atopic dermatitis remains a chronic and often debilitating condition for many patients, with significant gaps in current treatment options. He noted that Fast Track designation will allow the company to work more closely with the FDA and potentially speed up KT-621’s development. Dr. Mainolfi emphasized that Kymera aims to deliver a once-daily oral therapy with the effectiveness and safety profile typically associated with injectable biologics, but in a more convenient form that could improve access and outcomes for millions of patients affected by AD and other Type 2 inflammatory diseases.

Kymera recently shared positive findings from the BroADen Phase 1b trial in atopic dermatitis, where KT-621 demonstrated encouraging signs across all evaluated measures. These included strong STAT6 degradation, favorable biomarker and clinical activity responses, improvements related to comorbid Type 2 conditions, and a supportive safety profile. The company is now conducting the BROADEN2 Phase 2b trial in patients with moderate to severe AD, with results expected by mid-2027. Additionally, the BREADTH Phase 2b trial evaluating KT-621 in asthma is scheduled to begin in the first quarter of 2026. Insights from these studies will help determine appropriate dosing and support plans for multiple Phase 3 registration trials across dermatology, gastroenterology, and respiratory indications linked to Type 2 inflammation.

The FDA’s Fast Track designation is intended to speed the development and review of therapies that address serious medical conditions and unmet needs. This status provides companies with increased communication opportunities with the FDA, and, if certain criteria are met, could make KT-621 eligible for accelerated approval or priority review in the future.