Applied Genetic Technologies Corporation announced that the U.S. Food and Drug Administration (FDA) provided favorable feedback on the Current Good Manufacturing Practice (cGMP) design of AGTC's manufacturing facility. In its feedback from a recent Type C meeting, the FDA concurred the facility design and proposed operating procedures are appropriate to support the cGMP manufacture of recombinant AAV drug substance. In May 2022, AGTC announced that it had completed construction of the manufacturing facility's exterior structure and the FDA's feedback on the interior design of the facility helps assure the potential successful completion of next phase of construction.

Initial operations at the facility are expected to begin in Fourth Quarter 2022 with GMP capabilities expected to be finalized in First Quarter 2023.