BioMendics Receives FDA Fast Track Designation for BM-3103 (TolaSure® Gel™) for Epidermolysis Bullosa Simplex
BioMendics, LLC, a clinical-stage biotechnology company developing innovative therapies for rare genetic skin disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BM-3103, formulated as TolaSure® Gel™, for the treatment of Epidermolysis Bullosa Simplex (EBS). The milestone comes as the company prepares to attend the BIO International Convention 2026 in San Diego (June 22–25).
BioMendics Launches TAMES-02 Clinical Trial for Innovative Epidermolysis Bullosa Simplex Therapy
BioMendics, a clinical-stage biopharmaceutical company focused on rare skin diseases, today announced the launch of the TAMES-02 clinical trial—a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of TolaSure™, a first-in-class topical therapy for patients with generalized intermediate to severe Epidermolysis Bullosa Simplex (EB Simplex).
