Benitec Biopharma Announces Regulatory Update Following Type C Meeting with FDA for BB-301 Pivotal Study

The BB-301 pivotal trial remains on track to begin in mid-2027Discussions regarding an open-label, single-arm, pivotal study for BB-301 are ongoing, and based on these discussions, the FDA requested additional available data, including data from the Benitec-sponsored OPMD Natural History StudyFinal pivotal study design expected to be confirmed in 1Q 2027Benitec will present interim clinical results from the ongoing BB-301 Phase 1b/2a study as a late-breaking poster presentation, which will encom