AGTC receives positive feedback from FDA for manufacturing facility

Jul. 26, 2022 8:51 AM ETApplied Genetic Technologies Corporation (AGTC)By: Dania Nadeem, SA News Editor

Structure of human eye.


  • Applied Genetic Technologies (NASDAQ:AGTC) said the U.S. Food and Drug Administration had provided favorable feedback on the current Good Manufacturing Practice (cGMP) design of AGTC’s manufacturing facility.
  • The facility will support AGTC’s pipeline, including the late-stage development and potential commercialization of its eye diseases therapy like X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia B3 (ACHMB3) programs.
  • The company said initial operations at the facility are expected to begin in Q4 with GMP capabilities expected to be finalized in Q1 2023.
  • "We expect the facility will also play an important role in support of our promising pipeline of additional clinical and pre-clinical programs," the company said.
  • (AGTC) rose 1.3% premarket.

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