Detailed company information
REGENXBIO Inc. is a biotechnology company operating in the clinical stage, dedicated to developing gene therapy candidates. These therapies are designed to introduce genes into cells, aiming either to rectify genetic deficiencies or to stimulate the body's own cells to produce therapeutic proteins or antibodies to combat diseases. Central to its therapeutic development is the proprietary NAV Technology Platform, an adeno-associated virus-based gene delivery system. The company's primary investigational asset, RGX-314, is currently in Phase III clinical trials for treating wet age-related macular degeneration. Its pipeline also includes RGX-121 and RGX-111, both in Phase I/II trials for mucopolysaccharidosis type II and type I, respectively; RGX-181, which is in preclinical development for late-infantile neuronal ceroid lipofuscinosis type II disease; RGX-202, undergoing Phase I/II evaluation for Duchenne muscular dystrophy; and RGX-381, at the preclinical stage for addressing the ocular manifestations of CLN2 disease. In addition to its internal programs, REGENXBIO Inc. licenses its NAV Technology Platform to other biotech and pharmaceutical enterprises. It also maintains a collaborative and licensing agreement with Neurimmune AG for the advancement of innovative gene therapies. Founded in 2008, REGENXBIO Inc. maintains its headquarters in Rockville, Maryland.
Last Updated: Sep 2026
Earnings Transcript for 2026 - Q1Released: May 14, 2026
Earnings Transcript for 2025 - Q4Released: Mar 05, 2026
Earnings Transcript for 2025 - Q1Released: May 13, 2025
Earnings Transcript for 2024 - Q4Released: Mar 13, 2025
Earnings Transcript for 2024 - Q3Released: Nov 06, 2024
Earnings Transcript for 2024 - Q2Released: Aug 01, 2024
Earnings Transcript for 2024 - Q1Released: May 08, 2024
Earnings Transcript for 2023 - Q4Released: Feb 27, 2024
Earnings Transcript for 2023 - Q3Released: Nov 08, 2023
Earnings Transcript for 2023 - Q2Released: Aug 02, 2023
Earnings Transcript for 2023 - Q1Released: May 03, 2023
Earnings Transcript for 2022 - Q4Released: Feb 28, 2023
Earnings Transcript for 2022 - Q3Released: Nov 03, 2022
Earnings Transcript for 2022 - Q2Released: Aug 05, 2022
Earnings Transcript for 2022 - Q1Released: May 04, 2022
Earnings Transcript for 2021 - Q4Released: Mar 01, 2022
Earnings Transcript for 2021 - Q3Released: Nov 02, 2021
Earnings Transcript for 2021 - Q2Released: Aug 09, 2021
Earnings Transcript for 2021 - Q1Released: May 05, 2021
Earnings Transcript for 2020 - Q4Released: Mar 01, 2021
Earnings Transcript for 2020 - Q3Released: Nov 05, 2020
Earnings Transcript for 2020 - Q2Released: Aug 06, 2020
Earnings Transcript for 2020 - Q1Released: May 07, 2020
Earnings Transcript for 2019 - Q4Released: Feb 26, 2020
This discussion clarifies the FDA's expectations for REGENXBIO's RGX-202 pre-BLA meeting in 2026, focusing on the data package composition and the extent of functional exposure data needed for accelerated approval.
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