Posted by Michael Wonder on 23 Oct 2025
FDA grants fast track designation for AJ201, a first in class therapy for Kennedy's disease
23 October 2025 - AnnJi Pharmaceutical today announced that the US FDA has granted fast track designation for AJ201, the first in class for therapy for spinal and bulbar muscular atrophy (SBMA, also known as Kennedy's disease).
AJ201, also known as JM17, is a novel investigational compound that has shown potential in reducing mutant AR toxicity and improving motor function in pre-clinical SBMA models.
