secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2026-03-05T23:59:59+00:00
Accession:  0001193125-26-092566
Event type: earnings
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO Q4 net loss $67.1M; FDA holds on RGX-121/111; RGX-202 data expected Q2 2026
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- Q4 2025 net loss $67.1M ($1.30/sh) vs $51.2M loss ($1.01/sh) in Q4 2024; FY net loss $193.9M ($3.76/sh).
- Revenues for full year 2025 $170.4M (up from $83.3M in 2024) driven by Nippon Shinyaku partnership and royalty increases.
- Cash and marketable securities $240.9M at Dec 31, 2025; expects operations funded into early 2027.
- FDA placed clinical holds on RGX-121 and RGX-111; issued Complete Response Letter for RGX-121 BLA in Feb 2026.
- RGX-202 for Duchenne: topline pivotal data expected early Q2 2026; pre-BLA meeting mid-2026. Sura-vec wet AMD data expected Q4 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526092566/0001193125-26-092566-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526092566/rgnx-20260305.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-092566

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