Company: RGNX
Filing Date: 2025-11-26
Form Type: S-3
Source: 0001193125-25-300539
Chunk: 4

Company: REGENXBIO Inc.
Filing Date: 2025-11-26
Form: S-3
Chunk 4
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 commercialize RGX-121 
 and RGX-111;                                                                                                                     |

| • |     | our ability to obtain, including under accelerated approval, and maintain regulatory approval of our product 
 candidates, and the labeling for any approved products;                                                      |

| • |     | the timing of enrollment, commencement, completion and the success of our AAVIATE®, AFFINITY BEYOND®, AFFINITY DUCHENNE®, ALTITUDE®, ASCENT™, ATMOSPHERE®, 
 CAMPSIITE® and other clinical trials, including for diabetic retinopathy;                                                                                  |

| • |     | the timing of commencement and completion and the success of preclinical studies conducted by us and our 
 development partners;                                                                                    |

| • |     | the timely development and launch of new products; |

| • |     | the scope, progress, expansion and costs of developing and commercializing our product candidates; |

| • |     | our ability to obtain, maintain and enforce intellectual property protection for our product candidates and 
 technology, and defend against third-party intellectual property-related claims;                            |

| • |     | our expectations regarding the development and commercialization of product candidates currently being developed 
 by third parties that utilize our technology;                                                                    |

| • |     | our anticipated growth strategies; |

| • |     | our expectations regarding competition; |

| • |     | the anticipated trends and challenges in our business and the market in which we operate; |

| • |     | our ability to attract or retain key personnel; |

| • |     | the size and growth of the potential markets for our product candidates and the ability to serve those markets; |

| • |     | the rate and degree of market acceptance of any of our products that are approved; |

| • |     | our expectations regarding our expenses and revenue; |

| • |     | our expectations regarding our need for additional financing and our ability to obtain additional financing; |

| • |     | our expectations regarding the outcome of legal proceedings; |

| • |     | our expectations regarding regulatory developments in the United States and foreign countries; |

ii

| • |     | the impact of any government-imposed tariffs or other trade barriers on cost of goods and services, particularly 
 related to partnered product candidates; and                                                                     |

| • |     | changes in the financial markets and banking system that may affect the availability and terms on which we may                                             
 obtain financing and our ability to accurately predict how long our existing cash resources will be sufficient to fund