secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2026-08-24T21:20:14+00:00
Accession:  0001193125-26-363786
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA clinical hold on REGENXBIO's RGX-121 for MPS II; BLA resubmission not expected near term
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- FDA clinical hold on RGX-121 after asymptomatic spine MRI findings in 5 CAMPSIITE study participants.
- REGENXBIO does not expect to resubmit RGX-121 BLA in near term; longer follow-up and data analysis needed.
- All five participants clinically stable/improving; findings deemed nonserious, likely benign by investigators.
- Company reaffirms Duchenne BLA submission this quarter and wet AMD pivotal data in Q4.
- Hold follows earlier RGX-111 clinical hold; expanded MRI monitoring to include brain and spine.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526363786/0001193125-26-363786-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000119312526363786/rgnx-20260824.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-363786

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