Benitec Biopharma Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $313.9M
- Price
- $9.00
- % Change (Daily % change from the live per-ticker quote feed.)
- -2.49%
- Volume
- 217.2K
About
Benitec Biopharma Inc., a clinical-stage biotechnology company, focuses on the development of novel genetic medicines. Its Silence and Replace, a DNA-directedRNA interference platform combines RNA interference with gene therapy to create medicines that simultaneously facilitate sustained silencing of disease-causing genes and concomitant delivery of wildtype replacement genes following a single administration of the therapeutic construct. The company is developing BB-301, an AAV-based gene therapy designed to silence the expression of the disease-causing gene for the treatment of oculopharyngeal muscular dystrophy related dysphagia. Benitec Biopharma Inc. is headquartered in Hayward, California.
Quick stats
Shares outstanding34.9M
Computed float21.1M
Float / shares60.5%
Cash runway (months)115.6
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001808898
Websitehttps://benitec.com
AI Summary
AI-generated1/10
minorneutralregulatory
Benitec Biopharma Announces Regulatory Update Following Type C Meeting with FDA for BB-301 Pivotal Study
Benitec Biopharma received formal FDA feedback following a Type C meeting regarding the design of a proposed open-label, single-arm pivotal study for BB-301 in OPMD-related dysphagia.
The FDA requested additional available data, including results from the Benitec-sponsored OPMD Natural History Study, and agreed to a review timeline allowing final pivotal study design confirmation in 1Q 2027 with patient enrollment on track for mid-2027.
Interim Phase 1b/2a results will be presented at the ESGCT Annual Congress in Hamburg (October 27-30, 2026), covering 12-month follow-up for all six Cohort 1 patients and interim data for all three Cohort 2 patients.
Red flags
- FDA requested additional data before finalizing pivotal study design -- design not yet agreed and pivotal path still subject to Agency acceptance
- Clinical-stage company with ongoing losses and acknowledged need for additional financing per forward-looking statement risk factors