---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-261665"
form_type: "8-K"
ticker: "BNTC"
cik: "0001808898"
company_name: "Benitec Biopharma Inc."
filed_at: "2025-11-03T23:59:59+00:00"
generated_at: "2026-05-17T00:55:49.044718+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Benitec gets FDA Fast Track for BB-301 in OPMD; 100% response rate in Cohort 1

## Summary
- FDA granted Fast Track Designation to BB-301 for OPMD with dysphagia; BB-301 also has Orphan Drug Designation from FDA and EMA.
- All six Cohort 1 patients met statistical response criteria (100% response rate) with significant improvements in dysphagia measures.
- First Cohort 2 patient treated in Q4 2025; Benitec plans FDA meeting in 2026 to confirm pivotal study design.
- Appointed Dr. Sharon Mates to board; she was co-founder/CEO of Intra-Cellular Therapies (acquired by JNJ for ~$14.6B in 2025).

## SEC filing metadata
- accession: 0001193125-25-261665
- form_type: 8-K
- ticker: BNTC
- cik: 0001808898
- company_name: Benitec Biopharma Inc.
- filed_at: 2025-11-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 5.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1808898/000119312525261665/0001193125-25-261665-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1808898/000119312525261665/bntc-20251102.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-261665
- JSON: https://secwatch.observer/filing/0001193125-25-261665.json
- Plain text: https://secwatch.observer/filing/0001193125-25-261665.txt

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