---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-413177"
form_type: "8-K"
ticker: "BNTC"
cik: "0001808898"
company_name: "Benitec Biopharma Inc."
filed_at: "2026-10-05T12:08:08+00:00"
generated_at: "2026-10-12T14:45:27.626160+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.45
calibrated_materiality_score: 0.45
confidence: "high"
source: SEC EDGAR
---

# Benitec: FDA requests more BB-301 data; pivotal design due 1Q 2027, enrollment mid-2027

## Summary
- FDA formal feedback after a 3Q 2026 Type C meeting asked Benitec for additional available data, including results from the company-sponsored OPMD Natural History Study.
- Benitec expects to confirm the final design of the open-label, single-arm BB-301 pivotal study in 1Q 2027; patient enrollment planned to begin mid-2027, with timelines 'on track'.
- Interim Phase 1b/2a data to be presented as a late-breaking poster at ESGCT in Hamburg, Oct 27-30, 2026: 12-month follow-up for all six Cohort 1 patients, interim data for three Cohort 2 patients.
- CEO Jerel A. Banks said the requested data will go to the FDA 'in the coming weeks'; goal is BB-301 as the first approved disease-modifying therapy for OPMD-related dysphagia.

## SEC filing metadata
- accession: 0001193125-26-413177
- form_type: 8-K
- ticker: BNTC
- cik: 0001808898
- company_name: Benitec Biopharma Inc.
- filed_at: 2026-10-05T12:08:08+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.45
- calibrated_materiality_score: 0.45
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1808898/000119312526413177/0001193125-26-413177-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1808898/000119312526413177/bntc-20261005.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-413177
- JSON: https://secwatch.observer/filing/0001193125-26-413177.json
- Plain text: https://secwatch.observer/filing/0001193125-26-413177.txt

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