Bicara Therapeutics (BCAX) pivotal Fortifi-HN01 study in first-line recurrent/metastatic HPV-negative head and neck cancer remains on track for substantial enrollment by year-end, supporting a mid-2027 interim analysis that could enable accelerated approval, Wedbush Securities said in a Tuesday note.

The brokerage noted that Bicara also initiated Fortifi-Flex, evaluating a 12-week weekly loading regimen followed by maintenance dosing every three weeks with pembrolizumab.

Wedbush expects the alternative dosing schedule to preserve early TGF-beta suppression and show similar efficacy, with results expected by the time of a potential US accelerated approval.

Updated phase 1/1b data showed a three-year overall survival rate of 31%, about double that seen in retrospective pembrolizumab analyses, further supporting the durability of ficerafusp alfa's activity, the brokerage said.

Bicara named President and Chief Operating Officer Ryan Cohlhepp as CEO, effective January 2027, succeeding Claire Mazumdar, who will remain Vice Chair and Strategic Advisor. Wedbush does not view the transition as posing meaningful execution risk.

Wedbush reiterated its outperform rating and raised its price target to $33 from $30.

Shares of Bicara were down nearly 11% in Tuesday afternoon trading.

Price: 24.70, Change: -3.03, Percent Change: -10.93