-Fifth Subject in BB-301 Phase 1b/2a Clinical Treatment Study safely treated in February 2025- -Interim clinical study update to be presented in late-breaking oral presentation at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference on March 19, 2025- HAYWARD, Calif., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference ("ddRNAi") platform, today announced financial results for its second fiscal quarter ended December 31, 2024.
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-Positive 270-day Interim Clinical Study Data for the First Subject and Positive 180-day Interim Clinical Study Data for the Second Subject Treated with the Low-Dose of BB-301 in the Phase 1b/2a Clinical Treatment Study Reported in October as a Late-Breaking Oral Presentation at the 29 th Annual Congress of the World Muscle Society-
Benitec Biopharma Inc.'s BB-301 showed positive interim results in treating OPMD, allowing for higher dosing in 2025 and a potential late-stage trial in 2026. BB-301 demonstrated significant improvements in swallowing function and reduced pharyngeal residue, with no serious adverse events reported in the phase 1b/2a study. Financially, Benitec Biopharma is well-positioned with $50.9 million in cash, sufficient to fund operations through 2025, thanks to a $40 million PIPE financing.
-Management plans to host an investor webcast on October 14 th at 8:30 am EDT to provide an update for the BB-301 Phase 1b/2a Clinical Study, details below-
-Subject 1 and Subject 2 experienced durable, clinically meaningful improvements in swallowing at 9-months and 6-months post-BB-301 treatment, respectively, with Subject 2 achieving a Sydney Swallow Questionnaire Score Representative of Clinically Normal Swallowing-
-Positive 90-day and 180-day Interim Clinical Trial Data for the First Oculopharyngeal Muscular Dystrophy (OPMD) Subject Dosed with the Low-Dose of BB-301 in the Phase 1b/2a Clinical Treatment Study Reported in April and July-
-The post-dose average values for Total Pharyngeal Residue (i.e., the amount of solid food or liquid material remaining in the pharynx after the first swallow) remained meaningfully reduced at the 180-day post-dose assessment following the administration of the low dose of gene therapy BB-301 as compared to the pre-dose average values recorded for Subject 1 during the OPMD Natural History Study-