Regulatory ApprovalThe FDA lifted the clinical hold on the CATT1 Phase 3 trial after the company provided additional work around cadisegliatin, which is seen as a favorable strategic decision.
Regulatory RecognitionThe FDA granted Breakthrough Therapy Designation (BTD) to cadisegliatin, which expedites the development and review of new drugs, highlighting its potential for substantial improvements over existing therapies.
Therapeutic BenefitsCadisegliatin has demonstrated promising therapeutic benefits in managing type 1 diabetes, including a significant reduction in symptomatic hypoglycemic episodes and an absence of ketoacidosis in the Phase 2 SimpliciT1 study.