TD Cowen Reiterates Buy Rating on Benitec BioPharma (BNTC): "strong POC to support Ph3 success"

TD Cowen analyst Ritu Baral reiterated a Buy rating on Benitec BioPharma (NASDAQ: BNTC)

The analyst commented, "BNTC announced 1st interim Ph1/2 OL high-dose Cohort 2 data for '301 in OPMD dysphagia. The 1st high-dose pt responded to '301 via BNTC's OPMD responder index 1º EP at only 3mo post-tx, with robust, more rapid initial dose-response vs. a low-dose pt with similar BL disease. We see today's data as strong POC to support Ph3 success and look forward to FDA alignment on pivotal study design in mid-26... First interim high-dose first patient Ph1/2 '301 data gives strong POC to support '301's clinically meaningful efficacy in OPMD dysphagia, with initial robust early (especially vs low dose) signs of dose-response across all measures of OPMD dysphagia and BNTC's proprietary responder index 1º EP. Together with prior low-dose data showing a 100% 1-year response rate (n=4) and preliminary durability of efficacy out to 2-years post-tx (see here), we believe BNTC's current Ph1/2 '301 data package supports Ph3 success on a similar responder index 1º EP, an EP that we think will likely be accepted by FDA for approval. Recall, BNTC plans to meet with FDA in mid-2026 to receive formal input on their proposed pivotal trial design, including the proprietary responder index that is the proposed Ph3 pivotal EP, as well as registrational dose. We think the current efficacy data supports registration of the high dose if safety data continues to be benign. Data (to be more fully presented tomorrow at an MDA industry forum breakfast) further strengthens our conviction that FDA will sign off on a Ph3 OPMD trial design using BNTC's responder index as its 1º EP.

For an analyst ratings summary and ratings history on Benitec BioPharma click here. For more ratings news on Benitec BioPharma click here.

Shares of Benitec BioPharma closed at $11.34 yesterday.

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