Benitec Biopharma targets mid-2027 start for BB-301 pivotal trial in OPMD dysphagia
BNTC•Benitec Biopharma said its pivotal study of BB-301 for OPMD dysphagia remains on track to begin enrollment in mid-2027, with the final design expected in 1Q 2027 pending FDA review of additional data.
1. FDA discussions continue
The FDA requested additional data, including results from Benitec’s OPMD natural history study, as discussions continue on an open-label, single-arm pivotal design. Interim Phase 1b/2a results are scheduled for presentation as a late-breaking poster at ESGCT on Oct. 27-30, 2026.
