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

Benitec Biopharma Inc.

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.

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