secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2026-05-14T11:15:16+00:00
Accession:  0001193125-26-222768
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO RGX-202 Phase III meets primary endpoint (p<0.0001); Q1 net loss $90.1M
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- Primary endpoint achieved: 93% of patients >10% microdystrophin expression at Week 12 (p<0.0001); average expression 71.1%.
- Significant correlation between microdystrophin expression and functional improvement (NSAA, p=0.0002); supports surrogate endpoint for accelerated approval.
- Q1 2026 net loss $90.1M ($1.72/share) vs prior-year net income $6.1M; revenue fell to $6.4M from $89.0M (prior year milestone).
- Cash $150.5M at March 31 (vs $240.9M Dec 31); runway into early 2027; expects $100M AbbVie milestone upon first DR patient dosed in Q2 2026.
- FDA lifted clinical hold on RGX-121; company preparing for RGX-202 BLA submission targeting potential accelerated approval in 2027.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526222768/0001193125-26-222768-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526222768/rgnx-20260514.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-222768

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