Bicara Sets Phase 3 Path for Ficerafusp Alfa

Bicara Therapeutics Inc. ( (BCAX) ) has shared an announcement.

On January 12, 2026, Bicara Therapeutics announced it had selected a 1500 mg once-weekly dose of its lead asset, ficerafusp alfa, in combination with pembrolizumab as the optimal regimen for the Phase 3 FORTIFI-HN01 pivotal trial in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma, following alignment with the U.S. Food and Drug Administration. Building on clinical data showing more than a doubling of median overall survival versus standard of care in HPV-negative patients, the company laid out a 2026 roadmap centered on substantially enrolling the FORTIFI-HN01 trial by year-end to enable an interim analysis in mid-2027, presenting multiple Phase 1b data readouts in head and neck cancer and metastatic colorectal cancer, and making key commercial hires to prepare for a potential launch in a large, high-unmet-need market, thereby reinforcing ficerafusp alfa’s positioning as a potential blockbuster and “pipeline-in-a-product” within EGFR- and TGF-β–driven solid tumors.

The most recent analyst rating on (BCAX) stock is a Buy with a $28.00 price target. To see the full list of analyst forecasts on Bicara Therapeutics Inc. stock, see the BCAX Stock Forecast page.

Spark’s Take on BCAX Stock

According to Spark, TipRanks’ AI Analyst, BCAX is a Neutral.

The score is primarily supported by a strong, low-debt balance sheet, but it is held back by widening losses and sharply worsening free cash flow in TTM. Technicals are mixed with near-term weakness but longer-term trend support, while valuation is difficult due to negative earnings; the recent positive Phase 1b update provides a notable catalyst.

To see Spark’s full report on BCAX stock, click here.

More about Bicara Therapeutics Inc.

Bicara Therapeutics Inc. is a Boston-based, clinical-stage biopharmaceutical company focused on developing transformative bifunctional therapies for solid tumors. Its lead program, ficerafusp alfa, is a first-in-class bifunctional antibody that combines an EGFR-directed monoclonal antibody with a TGF-β ligand trap to overcome the fibrotic, immune-excluded tumor microenvironment and drive deeper, more durable responses, initially targeting head and neck squamous cell carcinoma and being explored in other solid tumors such as metastatic colorectal cancer.

Average Trading Volume: 700,199

Technical Sentiment Signal: Strong Buy

Current Market Cap: $907.2M

See more insights into BCAX stock on TipRanks’ Stock Analysis page.