secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2022-02-14T23:59:59+00:00
Accession:  0001193125-22-039357
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO RGX-314 Phase II ALTITUDE: 47% patients achieve ≥2-step DRSS improvement at 6 months vs 0% control
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- 47% of RGX-314 patients in Cohort 1 showed ≥2-step DRSS improvement at 6 months vs 0% control; up from 33% at 3 months.
- No drug-related serious adverse events or intraocular inflammation in 15 patients at 6 months; therapy well tolerated.
- Among NPDR patients (severity 47-53), 57% achieved ≥2-step improvement; among PDR patients, 38% achieved improvement.
- Enrollment ongoing for Cohorts 2 (5x10^11 GC/eye) and 3 (NAb-positive patients) with no prophylactic corticosteroid use.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312522039357/0001193125-22-039357-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312522039357/d312888d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-039357

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