Bicara Therapeutics has chosen a 1500 mg dose of ficerafusp alfa as the optimal level for its Phase 3 FORTIFI‑HN01 study in first‑line, HPV‑negative recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The decision, made earlier than the company’s original schedule, positions the trial for enrollment to begin in 2026 and an interim analysis in mid‑2027 that could support an accelerated filing with the FDA.
Ficerafusp alfa is a bifunctional antibody that simultaneously targets epidermal growth factor receptor (EGFR) and transforming growth factor‑β (TGF‑β), a strategy designed to improve tumor penetration and overcome resistance mechanisms. The drug has received FDA Breakthrough Therapy Designation when combined with pembrolizumab for the same indication, underscoring its clinical promise and the urgency of advancing the trial.
Bicara’s plan to accelerate enrollment and reach the interim analysis by mid‑2027 reflects confidence in the safety and efficacy data collected in earlier phases. The company also indicated that it will expand data readouts into other solid tumor indications, including colorectal cancer, as part of a broader pipeline strategy that seeks to leverage the dual‑target mechanism across multiple disease sites.
Management highlighted the company’s strong financial footing, noting a cash runway that extends into the first half of 2029 and a recent $165 million Series C financing completed in December 2023. The company remains unprofitable, but its balance sheet is robust, and the new dose selection is expected to reduce development risk and accelerate the path to commercialization.
Analysts have responded positively to the dose decision, with BTIG upgrading its rating to “Buy” and maintaining a $28.00 price target, while Mizuho has kept a “Neutral” stance with an $18.00 target. The upgrades reflect confidence in the clinical data, the accelerated trial timeline, and the company’s solid cash position.
The dose selection and accelerated timeline are expected to strengthen Bicara’s competitive position in the HNSCC market, a space with significant unmet need, and to enhance investor confidence in the company’s ability to translate clinical milestones into future revenue streams.
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