secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2026-06-29T11:15:14+00:00
Accession:  0001193125-26-286825
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO doses first patient in Phase IIb/III DR trial; earns $100M milestone from AbbVie
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- First patient dosed in Phase IIb/III NAAVIGATE trial of sura-vec for diabetic retinopathy using suprachoroidal delivery.
- Triggered $100M milestone payment from AbbVie, expected in July 2026.
- Phase IIb portion to enroll ~135 patients in U.S.; primary endpoint is ≥2-step DRSS improvement at one year.
- To present 2.5-year ALTITUDE and 5-year subretinal data at ASRS July 2026.
- Topline data from ATMOSPHERE and ASCENT pivotal trials expected Q4 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526286825/0001193125-26-286825-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526286825/rgnx-20260623.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-286825

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer