secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2025-08-18T23:59:59+00:00
Accession:  0000950170-25-109829
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends PDUFA date for RGX-121 BLA to February 8, 2026
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- PDUFA goal date extended from Nov 9, 2025 to Feb 8, 2026 for review of additional 12-month data from pivotal study (n=13).
- No safety concerns raised; pre-license inspection completed with no observations.
- Company to present updated pivotal data at ICIEM meeting in September 2025; commercial launch plans remain on track.
- RGX-121 would be first potential one-time therapy for MPS II (Hunter syndrome); holds FDA Orphan, Rare Pediatric, Fast Track, RMAT designations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000095017025109829/0000950170-25-109829-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000095017025109829/rgnx-20250818.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-109829

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