The FDA approved Tzield for stage 3 type 1 diabetes, and the therapy was given to children in Canada for the first time. Research also advanced on engineered islets and stem-cell treatments.
A case report details a 63-year-old woman with insulin autoimmune syndrome and Hashimoto thyroiditis, presenting with hypoglycemia as low as 27 mg/dL. Elevated insulin and autoantibody titers confirmed the diagnosis. Prednisolone therapy rapidly improved glycemic stability, and the patient remained euglycemic after tapering.
C-peptide is described as a key biomarker for beta cell function in type 1 diabetes and a potential surrogate endpoint for drug approval. Current trial endpoints remain difficult for disease-modifying therapies.
Diamyd Medical anticipates March 2026 interim results from its Phase 3 diabetes trial that could support a BLA pathway. Capricor Therapeutics awaits an August 2026 FDA decision on its Duchenne muscular dystrophy treatment BLA. Bicara Therapeutics prepares for Phase 3 study initiation of its oncology candidate toward future BLA submission.
