Significant Progress in BB-301 Clinical Trials

Written by Emily J. Thompson, Senior Investment Analyst

Source: Newsfilter

Updated: 4 days ago

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BNTC-8.47%

Should l Buy BNTC?

Source: Newsfilter

Responder Analysis: All four patients in Cohort 1 of the BB-301 study were formal responders at the 12-month follow-up, demonstrating durable responses to treatment, indicating the therapy's effectiveness in addressing Oculopharyngeal Muscular Dystrophy-related dysphagia.
Long-term Efficacy Observation: Patient 1 showed continued disease-modifying effects at the 24-month follow-up, with significant improvements in post-swallow residue and total dysphagic symptom burden, suggesting BB-301 may provide long-term therapeutic benefits.
FDA Meeting Scheduled: The company plans to engage with the FDA in mid-2026 to formalize the pivotal study design for BB-301, which will lay the groundwork for the successful progression of subsequent clinical trials.
Financial Status Update: As of December 31, 2025, the company reported $189 million in cash and cash equivalents, and despite an operating loss of $13.8 million, R&D expenses remained consistent with the previous year, reflecting the company's commitment to advancing clinical development.

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Analyst Views on BNTC

Wall Street analysts forecast BNTC stock price to rise

2 Analyst Rating

2 Buy

0 Hold

0 Sell

Moderate Buy

Current: 11.340

Low

32.00

Averages

32.00

High

32.00

Current: 11.340

Low

32.00

Averages

32.00

High

32.00

H.C. Wainwright

Raghuram Selvaraju

Buy

downgrade

$35 -> $32

2025-11-24

Reason

H.C. Wainwright

Raghuram Selvaraju

Price Target

$35 -> $32

AI Analysis

2025-11-24

downgrade

Buy

Reason

H.C. Wainwright analyst Raghuram Selvaraju lowered the firm's price target on Benitec Biopharma to $32 from $35 and keeps a Buy rating on the shares. The firm cites the completed equity financing for the target cut.

H.C. Wainwright

Buy

maintain

$28 -> $35

2025-11-04

Reason

H.C. Wainwright

Price Target

$28 -> $35

2025-11-04

maintain

Buy

Reason

H.C. Wainwright raised the firm's price target on Benitec Biopharma to $35 from $28 and keeps a Buy rating on the shares. The company reported "highly positive" interim data reported from the first six patients to receive BB-301, the analyst tells investors in a research note. The firm says all six patients in the ongoing Phase 1b/2a trial met the formal statistical criteria for positive response in the proprietary oculopharyngeal muscular dystrophy responder analysis. H.C. Wainwright increased BB-301's probability of approval to 45% from 40%.

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About BNTC

Benitec Biopharma Inc is a clinical-stage biotechnology company. The Company is focused on the advancement of novel genetic medicines. Its proprietary Silence and Replace deoxyribonucleic acid (DNA) -directed ribonucleic acid (RNA) interference platform combines RNA interference, or RNAi, with gene therapy to create medicines that simultaneously facilitate sustained silencing of disease-causing genes and concomitant delivery of wildtype replacement genes following a single administration of the therapeutic construct. The Company is developing Silence and Replace-based therapeutics (BB-301) for chronic and life-threatening human conditions including Oculopharyngeal Muscular Dystrophy (OPMD). BB-301 is an adeno-associated viral vector (AAV)-based gene therapy designed to silence the expression of disease-causing genes (to slow, or halt, the underlying mechanism of disease progression) and to simultaneously replace the mutant genes with normal, wildtype genes.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Benitec Reports Q2 Earnings Miss with Strategic Upgrade

4 days agoseekingalpha

Earnings Report Disappointment: Benitec's Q2 GAAP EPS of -$0.26 missed expectations by $0.03, resulting in a net loss of $11.8 million, indicating ongoing financial strain on the company.
Market Reaction: Despite the earnings miss, early data from Benitec's BB-301 project and a cash infusion provide support for its future development, leading to a bullish outlook from the market.
Rating Adjustment: Seeking Alpha's Quant Rating has classified Benitec's stock as bullish, reflecting analysts' confidence in its potential growth despite current financial challenges.
Historical Financial Data: Historical financial data for Benitec shows that, despite facing challenges, the company is striving to improve its operational efficiency and market positioning to better compete in the future.