Posted by Michael Wonder on 24 Jun 2026
BioMendics receives FDA fast track designation for BM-3103 (TolaSure Gel) for epidermolysis bullosa simplex
23 June 2026 - BioMendics today announced that the US FDA has granted fast track designation to BM-3103, formulated as TolaSure Gel, for the treatment of epidermolysis bullosa simplex.
BioMendics is conducting the TAMES-02 Phase 2 clinical trial, evaluating BM-3103 (TolaSure Gel) in patients with Epidermolysis Bullosa Simplex in collaboration with leading investigators at Northwestern University Feinberg School of Medicine and Stanford University School of Medicine.
