secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2025-03-13T23:59:59+00:00
Accession:  0000950170-25-038711
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO reports Q4 net loss $51.2M; BLA for RGX-121 submitted, Nippon Shinyaku partnership closed
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- Net loss $51.2M ($1.01/sh) in Q4 2024 vs $62.9M; full year $227.1M ($4.59/sh) vs $263.5M. Revenue $83.3M vs $90.2M.
- BLA for RGX-121 (MPS II) submitted; FDA approval expected 2H 2025. Nippon Shinyaku deal closed: $110M upfront, up to $700M milestones.
- RGX-202 Duchenne pivotal trial nearly 50% enrolled; completion expected 2025, BLA mid-2026. Phase I/II data show favorable safety and functional improvement.
- Cash and securities $244.9M at Dec 31, 2024 (vs $314.1M). With $110M Nippon upfront, cash runway into 2H 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000095017025038711/0000950170-25-038711-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000095017025038711/rgnx-20250313.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-038711

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