secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2021-11-12T23:59:59+00:00
Accession:  0001193125-21-328180
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO reports positive interim Phase II data for RGX-314; 71.8% reduction in anti-VEGF injections at 6 months
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- RGX-314 well tolerated across 50 patients in Cohorts 1-3; no drug-related SAEs.
- Cohort 2 (wet AMD) at 6 months: mean BCVA stable (-0.1 letters from Day1); 71.8% reduction in anti-VEGF burden; 40% injection-free.
- Cohort 1 (diabetic retinopathy) at 3 months: stable BCVA +2.6 letters vs +0.4 control.
- Company plans additional updates; enrollment ongoing in higher-dose cohorts 4/5.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312521328180/0001193125-21-328180-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312521328180/d142076d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-328180

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