Benitec Biopharma Inc Stock News

- Both low dose and high dose BB-301 continue to drive robust improvements in swallowing function for dysphagic Patients with Oculopharyngeal Muscular Dystrophy (OPMD) - 100% of Patients treated with BB-301 across both doses are formal Responders to therapy - Interim clinical results for Patients treated with high dose BB-301 demonstrate greater relative improvements at the 3-month post-treatme...

The BB-301 pivotal trial remains on track to begin in mid-2027 Discussions 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 Study Final pivotal study design expected to be confirmed in 1Q 2027 Benitec will present interim clinical ...

All six Cohort 1 (low dose BB-301) patients have completed the full 12-month post-treatment follow-up period, and Cohort 2 (high dose BB-301) is fully enrolled with all three patients having been safely treated A Type C meeting was held with the U.S. Food and Drug Administration in 3Q2026 to discuss the BB-301 pivotal study design, and meeting minutes are anticipated in October Additional inter...

Late-breaking abstract for BB-301 presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference in March demonstrated durable responses to low dose BB-301 at 12-months and 24-months post-treatment and further improvements in depth of response following treatment with high dose BB-301 at the 3-month post-treatment follow-up time-point, with both doses demonstrating dis...

- Interim clinical results for the BB-301 Phase 1b/2a study include 12-month post-treatment follow-up results for the first four Cohort 1 completers, 24-month post-treatment follow-up results for the first Cohort 1 Patient, and interim clinical results for the first Cohort 2 Patient - BB-301 is the only clinical-stage therapeutic agent in development for the treatment of dysphagia in patients d...