Business
REGENXBIO Reports Second Quarter 2022 Financial Results and Recent Operational Highlights
RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, remains on track for first BLA filing in
About this update from Regenxbio Inc.
[{"type":"text","content":"RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, remains on track for first BLA filing in 2024 Enrollment ongoing in the pivotal ATMOSPHERE® and ASCENT™ clinical trials of RGX-314 for the treatment of wet AMD using subretinal deliveryCompleted enrollment in Cohort 5 of the AAVIATE® trial of RGX-314 for the treatment of wet AMD using suprachoroidal deliveryCompleted enrollment in ALTITUDE® trial of RGX-314 for the treatment of diabetic retinopathy using suprachoroidal delivery AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 remains on track for dosing in the first half of 2023 Announced intention to file a BLA in 2024 using the accelerated approval pathway for RGX-121 for the treatment of MPS II; pivotal program is active and enrolling patients$682 million in cash, cash equivalents and marketable securities of as of June 30, 2022; operational runway into 2025Conference call Wednesday, August 3rd at 4:30 p.m. ETROCKVILLE, Md., Aug. 3, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the second quarter ended June 30, 2022, and recent operational highlights.\n\"Our '5x'25' strategy to have five gene therapies either on the market or in late-stage development by 2025 is progressing well,\" said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. \"Earlier today, we announced that the pivotal program for RGX-121, our AAV Therapeutic for the treatment of MPS II, is active and enrolling patients, making this our second program to enter this stage of development. We believe RGX-121 will advance rapidly through the clinic, supporting our intention to file a BLA in 2024 using the accelerated approval pathway. RGX-314, being developed in collaboration with AbbVie, is also progressing well. We have two ongoing pivotal trials evaluating RGX-314 for the treatment of wet AMD and remain on track for a BLA filing in 2024. As previously announced, we also have progressed our Phase II trials evaluating suprachoroidal delivery of RGX-314. With our significant progress over the first half of the year along with a strong balance sheet to support the advancement of our leading AAV-gene therapy pipeline, we reman confident in our ability to deliver meaningful therapies to patients.\"\nProgram Highlights and Milestones\nRGX-314: RG...