Welcome to our dedicated page for Benitec Biopharm news (Ticker: BNTC), a resource for investors and traders seeking the latest updates and insights on Benitec Biopharm stock.
Benitec Biopharma Inc. (NASDAQ: BNTC) is 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. News related to Benitec centers on the progress of its lead program, BB-301, a Silence and Replace-based gene therapy candidate in clinical development for dysphagia associated with Oculopharyngeal Muscular Dystrophy (OPMD), a chronic, life‑threatening genetic disorder.
Investors following BNTC news can expect detailed updates on clinical trial milestones from the ongoing Phase 1b/2a study of BB-301 (NCT06185673). Company press releases have highlighted interim data showing that all six patients in Cohort 1 met formal statistical criteria for response, with significant and sustained improvements across multiple measures of swallowing function and dysphagic symptom burden. Longer-term follow-up reports describe durable and deepening improvements at 24 months post-treatment for the first treated patient.
Benitec’s news flow also includes regulatory developments, such as the FDA’s Fast Track Designation for BB-301 and Orphan Drug Designations from both the FDA and EMA, as well as updates on interactions with the FDA regarding pivotal study design. In addition, the company regularly reports financial results in Forms 10‑Q and 10‑K, accompanied by press releases that discuss research and development spending, cash position, and capital-raising activities, including underwritten offerings and registered direct offerings of common stock.
Corporate governance and leadership items, such as the appointment of new board members with biotechnology and pharmaceutical experience, are also disclosed through Benitec’s news releases and related Form 8‑K filings. For investors and observers, the BNTC news page provides a centralized view of clinical data updates, regulatory designations, financing transactions, and corporate developments that shape the company’s progress as a clinical-stage gene therapy developer.
Benitec Biopharma (NASDAQ: BNTC) reported positive interim data from its Phase 1b/2a study of BB-301 for Oculopharyngeal Muscular Dystrophy (OPMD). Two subjects treated with the low-dose BB-301 showed durable, clinically meaningful improvements in swallowing at 9 and 6 months post-treatment, respectively.
Key findings include:
- No Significant Adverse Events reported
- Subject 1 experienced a 35% reduction in Sydney Swallow Questionnaire (SSQ) Total Score and significant improvements in videofluoroscopic swallowing study (VFSS) assessments
- Subject 2 achieved an 89% reduction in SSQ Total Score, reaching a clinically normal swallowing profile
- Strong correlation between SSQ scores and VFSS Total Pharyngeal Residue results
These results represent the first reported successful improvements in swallow function using a novel gene therapy for OPMD. Benitec plans to treat a third subject with the low dose and enroll additional subjects at higher doses in 2025.
Benitec Biopharma Inc. (NASDAQ: BNTC) has released its full year 2024 financial results and operational update. Key highlights include:
- Positive 90-day and 180-day interim clinical trial data for the first OPMD subject dosed with low-dose BB-301
- Second subject dosed in February 2024, third expected in Q4 2024
- Closed $40.0 million private placement financing in April, extending cash runway through 2025
- Total revenues were $0 for FY2024, compared to $75,000 in FY2023
- Total expenses increased to $22.5 million in FY2024 from $19.2 million in FY2023
- Net loss of $22.4 million, or $5.51 per share, compared to $19.6 million, or $14.12 per share in FY2023
- Cash and cash equivalents of $50.9 million as of June 30, 2024
Benitec Biopharma Inc. (NASDAQ: BNTC) announced that a Late Breaking Abstract on BB-301 has been accepted for oral presentation at the 29th Annual Congress of the World Muscle Society in Prague, Czech Republic, from October 8-12, 2024. The presentation, scheduled for October 12, 2024, will focus on interim clinical data from a Phase 1b/2a study evaluating the safety and clinical activity of BB-301, an AAV9-based gene therapy for Oculopharyngeal Muscular Dystrophy (OPMD) with dysphagia. Professor Milan R. Amin, M.D., from the New York University Grossman School of Medicine, will present the findings. This presentation represents a significant milestone in Benitec's development of novel genetic medicines using their proprietary 'Silence and Replace' DNA-directed RNA interference (ddRNAi) platform.
Benitec Biopharma (NASDAQ: BNTC) announced that CEO Jerel A. Banks, M.D., Ph.D., will participate in the Oculopharyngeal Muscular Dystrophy (OPMD) Awareness Day Webinar on September 23, 2024, at 12 PM EST. The event, organized by the OPMD Association, aims to raise awareness about OPMD, a rare, genetic, adult-onset, progressive myopathy.
Dr. Banks will provide an update on the BB-301 Phase 1b/2a clinical development program. The webinar will offer patients, families, and caregivers clinical insights, patient perspectives, and informational resources to support understanding and care for OPMD. Benitec Biopharma is a clinical-stage biotechnology company developing novel genetic medicines based on its proprietary 'Silence and Replace' DNA-directed RNA interference (ddRNAi) platform.
Benitec Biopharma (NASDAQ: BNTC) reports continued improvements in swallowing efficiency for the first OPMD subject treated with low-dose BB-301 in their Phase 1b/2a study. At the 180-day post-dose assessment, Total Pharyngeal Residue (TPR) remained meaningfully reduced compared to pre-dose values. For three of four food types, TPR values were lower than at any point during the 9-month pre-dose observation period.
The Sydney Swallow Questionnaire (SSQ) Total Score showed continued reductions in dysphagic symptoms, indicating improved swallowing function. Both TPR and SSQ scores are considered central markers for evaluating clinical improvement in OPMD patients. The company plans to dose the third subject in Q3 2024 and report additional interim results in Q1 2025.
Benitec Biopharma, a clinical-stage gene therapy-focused biotechnology company, has appointed Kishen Mehta to its board of directors, effective June 26, 2024. This follows a $40 million PIPE financing led by Suvretta Capital, where Mehta is a portfolio manager. CEO Jerel A. Banks emphasized Mehta's expertise in investing, corporate development, and strategy, particularly as the company advances its Phase 1b/2a study for BB-301, a treatment for Oculopharyngeal Muscular Dystrophy (OPMD). Mehta brings over 15 years of financial industry experience, including roles at Biohaven Pharmaceuticals, Surveyor Capital, and Adage Capital, with a focus on healthcare investments. He expressed enthusiasm for contributing to Benitec's mission to develop effective treatments for OPMD patients.
Benitec Biopharma reported positive interim clinical trial data for the first Oculopharyngeal Muscular Dystrophy (OPMD) subject dosed with BB-301, with improvements noted in swallowing assessments. The company closed an oversubscribed $40.0 million private financing round extending cash runway through 2025. Operational updates include enrollment of 23 subjects in the OPMD Natural History Study and milestones related to BB-301 development.
Benitec Biopharma Inc. (BNTC) will participate in the Citizens JMP Life Science Conference in New York on May 13-14, 2024, presenting its gene therapy-focused ddRNAi platform. The presentation by Jerel Banks, MD, PhD, Executive Chairman and CEO, will be webcasted live.
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