secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2025-01-14T23:59:59+00:00
Accession:  0001193125-25-005659
Event type: m_and_a
Sentiment:  positive
Materiality: 0.85
Item codes: 1.01, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO licenses RGX-121/RGX-111 to Nippon Shinyaku for $110M upfront, up to $700M milestones
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- Upfront $110M, milestones up to $700M ($40M dev/reg, $660M sales), plus double-digit royalties on net sales in U.S. and Asia.
- REGENXBIO retains 100% of proceeds from RGX-121 Priority Review Voucher; rolling BLA submitted, potential FDA approval late 2025.
- Nippon Shinyaku to commercialize in Licensed Territory (U.S., Asia); REGENXBIO leads manufacturing and retains rest-of-world rights.
- RGX-111 for MPS I (Hurler) also included; Phase 1/2 results promising. Deal expected to close by end of Q1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312525005659/0001193125-25-005659-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312525005659/d868307d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-005659

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