Bicara Therapeutics Receives Breakthrough Therapy Designation from U.S. FDA for Ficerafusp Alfa in First-Line Treatment of HPV-Negative Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 13 2025
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Source: Newsfilter
FDA Breakthrough Therapy Designation: Bicara Therapeutics has received FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for treating metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with specific tumor characteristics, highlighting the urgent need for effective therapies in this area.
Clinical Trial Insights: The designation is supported by promising Phase 1/1b trial results showing a median duration of response of 21.7 months and overall survival of 21.3 months, indicating the potential of ficerafusp alfa to provide significant clinical benefits for patients with HPV-negative HNSCC.
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Analyst Views on BCAX
Wall Street analysts forecast BCAX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BCAX is 30.44 USD with a low forecast of 11.00 USD and a high forecast of 48.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
10 Analyst Rating
8 Buy
2 Hold
0 Sell
Strong Buy
Current: 16.590
Low
11.00
Averages
30.44
High
48.00
Current: 16.590
Low
11.00
Averages
30.44
High
48.00
About BCAX
Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Its lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR), directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation and the immunosuppressive TGF-b signaling within the tumor microenvironment. Ficerafusp alfa is initially being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need. Its platform is designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site.
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.
Bicara Therapeutics Reports Efficacy Data for 750mg Dose of Ficerafusp Alfa
- Efficacy Data Presentation: At the ESMO Asia Congress, Bicara Therapeutics presented preliminary data showing a 57% confirmed overall response rate for 750mg ficerafusp alfa combined with pembrolizumab, with 10% of patients achieving a complete response, indicating significant potential for treating HPV-negative recurrent/metastatic head and neck squamous cell carcinoma.
- Safety Analysis: The safety profile of the 750mg dose was consistent with the known safety of ficerafusp alfa plus pembrolizumab, demonstrating good tolerability in clinical applications and providing confidence for further research.
- Dose Optimization Plan: Bicara plans to declare the optimal biologic dose for the FORTIFI-HN01 study in the first quarter of 2026, further advancing clinical trial progress and aiming to accelerate the approval process for this therapy.
- TGF-β Inhibition Impact: Data from the 1500mg dose showed greater TGF-β inhibition, with a median depth of response of 82% compared to 63% for the 750mg dose, suggesting that higher doses may lead to more durable clinical outcomes, addressing the urgent need for effective treatments among patients.
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Bicara Therapeutics Reports 57% Response Rate for 750mg Ficerafusp Alfa in HNSCC Study
- Clinical Trial Progress: Bicara Therapeutics presented preliminary data at the ESMO Asia Congress showing a 57% confirmed overall response rate for 750mg Ficerafusp alfa combined with Pembrolizumab, with 10% of patients achieving a complete response, indicating significant potential in treating HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
- Dose Optimization Strategy: The data suggest that the 1500mg dose of Ficerafusp alfa achieves greater TGF-β inhibition in the tumor microenvironment, resulting in a median depth of response of 82%, compared to 63% for the 750mg dose, providing strong support for pursuing accelerated approval.
- Safety Analysis: The safety profile of 750mg Ficerafusp alfa in combination with Pembrolizumab was consistent with known safety data, demonstrating good tolerability and enhancing confidence in this treatment regimen.
- Future Outlook: Bicara plans to declare the optimal biologic dose for the FORTIFI-HN01 study in the first quarter of 2026, further advancing the clinical development of this therapy to meet the urgent market demand for effective treatment options.
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