secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2024-08-01T23:59:59+00:00
Accession:  0000950170-24-089278
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO Q2 net loss $53M; advances RGX-202 pivotal and RGX-121 BLA
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- Q2 2024 net loss of $53.0M ($1.05 per share); revenue $22.3M (up 12% YoY) on Zolgensma royalties.
- Cash $327.3M at June 30, 2024; runway into 2026, excluding potential $200M AbbVie milestone.
- RGX-202 (Duchenne): consistent high microdystrophin expression; EOP2 supports accelerated approval; pivotal trial start Q4 2024.
- RGX-121 (MPS II): rolling BLA submission begins Q3 2024 under accelerated approval pathway.
- ABBV-RGX-314 (diabetic retinopathy): EOP2 meeting accelerated to Q4 2024; global pivotal trial planned H1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000095017024089278/0000950170-24-089278-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000095017024089278/rgnx-20240801.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-089278

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