Kymera Therapeutics’ KT-621 in dermatitis granted Fast Track Designation by FDA

Kymera Therapeutics (KYMR) announced that the FDA has granted Fast Track designation to KT-621, its first-in-class, oral STAT6 degrader, for the treatment of moderate to severe atopic dermatitis, or AD. The company recently reported positive results from the BroADen Phase 1b AD trial, in which KT-621 demonstrated the potential to provide a once-daily oral treatment for Type 2 inflammatory diseases across every measure evaluated, including STAT6 degradation, biomarker modulation, clinical activity, impact on comorbid Type 2 diseases, and safety. The KT-621 BROADEN2 Phase 2b trial in moderate to severe AD patients is ongoing, with data expected to be reported by mid-2027. The BREADTH Phase 2b trial in asthma is planned to start in Q1 2026. These studies are intended to accelerate KT-621 development and enable dose selection for subsequent parallel Phase 3 registration studies across multiple Type 2 dermatology, gastroenterology and respiratory indications.