secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2025-05-12T23:59:59+00:00
Accession:  0000950170-25-069211
Event type: earnings
Sentiment:  positive
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO Q1 net income $6.1M; revenue up 471% to $89M on Nippon Shinyaku deal
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- Net income $6.1M ($0.12 EPS) vs net loss $63.3M ($1.38 loss) in Q1 2024.
- Revenue $89.0M (vs $15.6M) driven by $71.8M license revenue from Nippon Shinyaku partnership.
- Cash $272.7M; operations funded into 2H 2026; guidance excludes milestone payments and PRV.
- RGX-202 Duchenne pivotal trial >50% enrolled; BLA submission on track for mid-2026.
- FDA expected to accept BLA for clemidsogene lanparvovec (RGX-121) in May; potential 2025 approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000095017025069211/0000950170-25-069211-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000095017025069211/rgnx-20250512.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-069211

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