secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2022-02-09T23:59:59+00:00
Accession:  0001193125-22-032205
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 reports positive interim Phase I/II data for RGX-121 (MPS II) and RGX-111 (MPS I)
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- Both RGX-121 (13 pts) and RGX-111 (5 pts + single-patient IND) well-tolerated with no drug-related SAEs.
- RGX-121: Dose-dependent CSF biomarker reductions; Cohort 3 D2S6 near normal levels at last follow-up.
- RGX-111: CSF heparan sulfate decreased in all 4 patients; IDUA enzyme detected in 3 of 4 post-dose.
- Neurodevelopmental improvement: RGX-121 patients (Cohorts 1-2) show skill acquisition up to 2 years; RGX-111 shows gains in younger and one older patient.
- Next steps: RGX-121 Cohort 3 expansion with cGMP material planned 1H2022; RGX-111 Cohort 2 expanded to enroll up to 6 more patients.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312522032205/0001193125-22-032205-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312522032205/d276078d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-032205

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