secwatch.observer — SEC 8-K summary
======================================

Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2025-11-06T23:59:59+00:00
Accession:  0001193125-25-268101
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO reports Q3 2025 net loss $61.9M; pipeline advances with key milestones
--------------------------------------------------------------------------------

- Net loss $61.9M ($1.20/sh) vs $59.6M ($1.17/sh) in Q3 2024; revenue $29.7M (+23% YoY).
- Cash, equivalents $302M as of Sep 30, 2025; cash runway into early 2027.
- RGX-202 Duchenne pivotal enrollment complete (n=30); topline early Q2 2026, BLA mid-2026.
- RGX-121 (MPS II) PDUFA date Feb 8, 2026; CSF biomarker reduction >80% sustained at 1 year.
- Sura-vec wet AMD pivotal enrollment complete (n=1,200+); topline Q4 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312525268101/0001193125-25-268101-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312525268101/rgnx-20251106.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-268101

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