EX-99.1 2 rgnx-ex99_1.htm EX-99.1 EX-99.1 EXHIBIT 99.1 REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone - New long-term data from diabetic retinopathy and wet AMD programs to be presented at American Society of Retina Specialists (ASRS) 2026 ROCKVILLE, Md., June 29, 2026 - REGENXBIO Inc. (Nasdaq: RGNX) today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery. REGENXBIO will receive $100 million from AbbVie for this milestone. “Dosing the first patient in the Phase IIb/III study is a significant milestone in our commitment with AbbVie to bring a one-time gene therapy to patients who continue to face progressive and vision-threatening complications across multiple chronic retinal diseases,” said Steve Pakola, M.D., Chief Medical Officer, REGENXBIO. “We are excited to advance sura-vec for DR, following the two-year data that reinforced the durable and disease-modifying impact that sura-vec has the pote…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
REGENXBIO Inc.
RGNXNASDAQEQUITYCurrent
Other Events
Item 8.01. Other Events. On June 29, 2026, REGENXBIO Inc. (the “Company”) announced that it has earned a milestone payment of $100.0 million from AbbVie Global Enterprises Ltd. (“AbbVie”), a subsidiary of AbbVie Inc., pursuant to the Collaboration and License Agreement, dated as of September 10, 2021 between the Company and AbbVie, as amended on August 5, 2025.…
Company context
REGENXBIO is a biotechnology company on a mission to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the field of AAV gene therapy. REGENXBIO is advancing a late-stage pipeline of one-time treatments for rare and retinal diseases, including RGX-202 for the treatment of Duchenne; surabgene lomparvovec (ABBV-RGX-314) for the treatment of wet AMD and diabetic retinopathy, in collaboration with AbbVie, and NAVSUNLI™ (clemidsogene lanparvovec-sngl, RGX-121) for the treatment of MPS II and RGX-111 for the treatment of MPS I, both in partnership with Nippon Shinyaku. Thousands of patients have been treated with REGENXBIO's AAV platform, including those receiving Novartis' ZOLGENSMA®. REGENXBIO's investigational gene therapies have the potential to change the way healthcare is delivered for millions of people. For more information, please visit www. REGENXBIO.com.
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Recent company filings
- Entry into a Material Definitive AgreementSep 23, 2026
- Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory ArrangementsAug 25, 2026
- Regulation FD Disclosure · Other EventsAug 24, 2026
- 10-Q filingAug 6, 2026
- Results of Operations and Financial ConditionAug 6, 2026