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FDA requests additional data for BB-301 pivotal study, design expected in 1Q 2027
BNTCBenitec Biopharma Inc.
Benitec Biopharma received formal feedback from the U.S. Food and Drug Administration following a Type C meeting regarding its BB-301 pivotal trial. The FDA requested additional available data, including results from the Benitec-sponsored OPMD Natural History Study, to support discussions on an open-label, single-arm study design. Final confirmation of the pivotal study design is expected in the first quarter of 2027, with patient enrollment planned to begin in mid-2027. The company will present interim clinical results from its ongoing Phase 1b/2a study at the European Society of Gene and Cell Therapy Annual Congress in October 2026. Benitec Biopharma is a clinical-stage biotechnology company developing disease-modifying genetic medicines based on its proprietary ddRNAi platform.