- 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.
For further details see:
AGTC receives positive feedback from FDA for manufacturing facility