Company: RGNX
Filing Date: 2025-08-07
Form Type: 8-K
Source: 0001193125-25-174947
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Company: REGENXBIO Inc.
Filing Date: 2025-08-07
Form: 8-K
Item: Item 1.01
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Item 1.01. Entry into a Material Definitive Agreement.

Amendment to License Agreement with AbbVie

On August 5, 2025, REGENXBIO Inc. (the “ Company”) and AbbVie Global Enterprises Ltd. (“ AbbVie”), a subsidiary of AbbVie Inc., entered into a First Amendment (the “ Amendment”) to the Collaboration and License Agreement, dated as of September 10, 2021 (the “ Collaboration Agreement”) by and between the Company and AbbVie. The Amendment modifies the development plan and related milestone structure for the diabetic retinopathy (“ DR”) program and adds an additional AbbVie-led investment to support the subretinal wet age-related macular degeneration (“wAMD”) program.

Under the Amendment, the Company will conduct the first registration enabling trial for DR suprachoroidal (“ SCS”) treatment as a combined Phase IIb/III trial performed in two parts (Part 1 and Part 2), and AbbVie will conduct the second registration enabling trial as a separate, standalone Phase III trial. In lieu of the $200 million milestone due under the Collaboration Agreement upon first patient dosed in the first registration enabling trial for DR SCS treatment, AbbVie will pay the Company $100 million upon first patient dosed in the Phase IIb/III trial for DR SCS treatment and an additional $100 million upon first patient dosed in the subsequent Phase III trial under the Amendment. AbbVie will also lead a new Phase IIIb randomized controlled study (the “ ACHIEVE Study”) to assess the injection burden, adverse events, change in disease activity, and long-term preservation of visual acuity of surabgene lomparvovec (sura-vec, ABBV-RGX-314) in adult participants with neovascular AMD. In exchange for AbbVie covering all the ACHIEVE Study costs, the Company will pay for its costs to conduct Part 1 of the Phase IIb/III SCS DR Study.