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REGENXBIO Reports Second Quarter 2023 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 2025ABBV-RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVieInterim results from Phase II AAVIATE® and ALTITUDE® trials of dose level 3 cohorts with short-course prophylactic steroid eye drops resulted in zero cases of intraocular inflammationAdditional interim efficacy data from the Phase II AAVIATE and ALTITUDE trials expected at upcoming medical conferences in second half 2023 and first half 2024Interim data from Phase II Bridging Study evaluating subretinal delivery of ABBV-RGX-314 produced by the NAVXpress™ platform process demonstrated the anticipated clinical profile in the low dose cohort: well-tolerated and with the majority of subjects (11/15, 73%) injection-free through six monthsInitial safety results from Cohort 1 of the Phase I/II AFFINITY DUCHENNETM trial of RGX-202 support well-tolerated profile; initial microdystrophin protein expression levels from Cohort 1 to be presented at World Muscle Society meeting in OctoberCompleted enrollment of the Phase III part of CAMPSIITE™ clinical trial of RGX-121 for treatment of MPS II; remains on track to file BLA in 2024 using the accelerated approval pathway$415 million in cash, cash equivalents and marketable securities as of June 30, 2023; operational runway into 2025Conference call Wednesday, August 2, 2023, at 4:30 PM (EDT)ROCKVILLE, Md., Aug. 2, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the second quarter ended June 30, 2023, and recent operational highlights.\n \"We continue to stay on track advancing our '5x'25' vision to have five gene therapies either on the market or in late-stage development by 2025,\" said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. \"We are executing against a transformational year for REGENXBIO, with multiple clinical milestones and updates anticipated in 2023. The encouraging safety and tolerability data for the high-dose cohorts of our in-office wet AMD and DR programs further validate the potential of the suprachoroidal space for AAV delivery to treat chronic retinal diseases. We successfully reached our goal of enrolling patients in CA...