secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2024-05-08T23:59:59+00:00
Accession:  0000950170-24-055656
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO Q1 net loss $63.3M; RGX-202 selects pivotal dose; cash $380.5M
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- Net loss $63.3M ($1.38 diluted EPS) vs $66.7M ($1.53) YoY; revenue $15.6M, down from $19.1M.
- Cash, equivalents and marketable securities $380.5M (up from $314.1M), runway into 2026.
- RGX-202 Duchenne: pivotal dose DL2 selected; second patient showed 20.9% microdystrophin expression, 90% CK reduction.
- ABBV-RGX-314 DR: positive interim ALTITUDE data; end-of-Phase II meeting FDA Q1 2025; pivotal trial H1 2025.
- RGX-121 BLA filing on track for 2024 via accelerated approval; potential Priority Review Voucher.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000095017024055656/0000950170-24-055656-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000095017024055656/rgnx-20240508.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-055656

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