Benitec Biopharma Inc. BNTC
Benitec Biopharma Inc. (Nasdaq: BNTC) is a rare genetic drug developer. Its lead program, BB-301 (AAV9 'Silence and Replace' ddRNAi gene therapy), is in Phase 2 for Oculopharyngeal muscular dystrophy (OPMD)-related dysphagia. Its next catalyst on record is BB-301: Benitec plans to advance BB-301 toward pivotal study in mid-2027. (H1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: BB-301 — Benitec plans to advance BB-301 toward pivotal study in mid-2027. (H1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| BB-301 | OPMD-related dysphagia (Phase 1b/2a, NCT06185673; Cohort 1 low dose complete, Cohort 2 high dose fully dosed) | gene therapy | Phase 2 |
Recent results and decisions
- Oct 28, 2026positive Benitec reports positive interim Phase 1b/2a results showing 100% of patients treated with BB-301 at both low and high doses are formal responders with robust improvements in swallowing function.
100% of Patients treated with BB-301 across both doses are formal Responders to therapy
Filing - Nov 3, 2025positive BB-301 Phase 1b/2a Cohort 1: all 6 patients met responder criteria (100%), no treatment-related severe AEs; some improvements still pending source data verification.
100% of Patients in Cohort 1 (n = 6) Were Responders
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.