---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-174479"
form_type: "8-K"
ticker: "BNTC"
cik: "0001808898"
company_name: "Benitec Biopharma Inc."
filed_at: "2023-06-26T23:59:59+00:00"
generated_at: "2026-06-13T17:12:44.416350+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Benitec Biopharma receives FDA IND clearance for BB-301 gene therapy for OPMD

## Summary
- FDA cleared IND for BB-301, a silence-and-replace gene therapy for Oculopharyngeal Muscular Dystrophy (OPMD).
- OPMD affects ~15,000 patients in US, Canada, Western Europe, and Israel; no approved therapies currently.
- First subject dosing expected in H2 2023 after rollover from ongoing Natural History study (13 subjects enrolled).
- Interim safety and efficacy data from Phase 1b/2a study to be reported every ~90 days post-dosing.
- BB-301 designed to treat OPMD-related dysphagia, a life-threatening swallowing disorder.

## SEC filing metadata
- accession: 0001193125-23-174479
- form_type: 8-K
- ticker: BNTC
- cik: 0001808898
- company_name: Benitec Biopharma Inc.
- filed_at: 2023-06-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1808898/000119312523174479/0001193125-23-174479-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1808898/000119312523174479/d516975d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-174479
- JSON: https://secwatch.observer/filing/0001193125-23-174479.json
- Plain text: https://secwatch.observer/filing/0001193125-23-174479.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.