Benitec Biopharma Provides Positive Interim Clinical Study Results for BB-301 Phase 1b/2a Clinical Trial and Receives FDA Fast Track Designation for BB-301
Benitec Biopharma Inc. (BNTC)
US:NASDAQ Investor Relations:
benitec.com/for-investors/investor-faqs
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Source: GlobeNewswire
Fast Track Designation was granted for BB-301 following FDA review of positive interim clinical study results and proprietary Responder Analysis planned for use in pivotal study for BB-301 BB-301 has also been granted Orphan Drug Designation from both FDA and EMA All six patients enrolled into Cohort 1 met the formal statistical criteria for response to BB-301, representing a 100% response rate Following the administration of BB-301, Cohort 1 patients experienced significant continuing reductions in dysphagic symptom burden, post-swallow residue accumulation, time required to consume fixed volumes of liquid, and improved pharyngeal closure during swallowing First patient in Cohort 2 successfully treated with BB-301 in fourth quarter of 2025Benitec plans to meet with the FDA in 2026 to confirm the BB-301 pivotal study designDr. Sharon Mates, who served as Chairman, Chief Executive Officer, and Co-founder of Intra-Cellular Therapies Inc., appointed to the Benitec Biopharma Board of
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BNTC
Earnings
- 11/14/25 - Beat
BNTC
Sec Filings
- 12/3/25 - Form SCHEDULE
- 12/3/25 - Form 4
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