Dynacure, a clinical stage biotechnology company, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its lead product candidate, DYN101. The Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and address significant unmet medical need.
DYN101 is currently being studied in UNITE-CNM, a multicenter phase 1/2 clinical trial for the two most common forms of CNM, X-linked myotubular myopathy (XLMTM) and autosomal dominant CNM (ADCNM). Initial data from this ongoing ascending dose study is expected within the second half of 2022.
