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REGENXBIO Reports Fourth Quarter 2022 and Full-Year 2022 Financial Results and Recent Operational Highlights
Continued progress on '5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and licensed programs into pivotal-stage or
About this update from Regenxbio Inc.
[{"type":"text","content":"Continued progress on '5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and licensed programs into pivotal-stage or commercial products by 2025RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVieEnrollment ongoing in the pivotal ATMOSPHERE® and ASCENT™ clinical trials using subretinal delivery, expected to support BLA filing in 2024Recently announced interim data from the Phase II pharmacodynamic study supports use of NAVXpress™ platform process in future commercialization plansRecently announced cohort expansions in AAVIATE® and ALTITUDE® suprachoroidal clinical trials on track to be completed in the first half of 2023; expected interim trial updates in the second half of 2023AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and recruiting patients; anticipated to report initial trial data in the second half of 2023CAMPSIITE™ clinical trial of RGX-121 for the treatment of MPS II on track to complete pivotal program enrollment in the first half of 2023; recent updates continue to support plan to file BLA in 2024 using the accelerated approval pathway $565 million in cash, cash equivalents and marketable securities as of December 31, 2022; operational runway into 2025Conference call Tuesday, February 28th at 4:30 p.m. ETROCKVILLE, Md., Feb. 28, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the fourth quarter and full-year ended December 31, 2022, and recent operational highlights.\n\"REGENXBIO enters the year with a strong pipeline of AAV Therapeutics. One year ago, we introduced our '5x'25' strategy and I remain confident that we will achieve this goal,\" said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. \"Our lead candidate, RGX-314, is being developed in partnership with AbbVie for the treatment of wet AMD and diabetic retinopathy, which present opportunities to make an impact in eye care for millions of patients. In 2022, we made meaningful progress with our RGX-314 trial enrollment objectives and geographic expansion planning. We also established in-house manufacturing to meet global clinical and commercial regulatory standards. We remain committed to developing treatments for rare diseases and made significant advancements with our pipeline of treatments...