Shares of Bicara Therapeutics Inc. (NASDAQ:BCAX) jumped 9.4% in Monday premarket trading after the company announced that its investigational cancer therapy ficerafusp alfa has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA).
The designation applies to ficerafusp alfa in combination with pembrolizumab as a first-line treatment for patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1, excluding HPV-positive cases.
The FDA’s decision was supported by Phase 1/1b cohort data evaluating the combination therapy in HPV-negative HNSCC patients. Results presented at the 2025 American Society of Clinical Oncology Annual Meeting showed a median duration of response of 21.7 months and median overall survival of 21.3 months, along with a favorable safety profile.
“BTD provides external validation of the importance of ficerafusp alfa’s best-in-disease potential, and solidifies the foundation for our ongoing pivotal trial, FORTIFI-HN01,” said Claire Mazumdar, Chief Executive Officer of Bicara Therapeutics.
The Breakthrough Therapy Designation aims to accelerate the development and review of drugs that demonstrate substantial improvement over available therapies for serious conditions. It gives Bicara greater access to FDA guidance, senior agency engagement, and eligibility for rolling and priority review.
Bicara, a clinical-stage biopharmaceutical company, is focused on advancing bifunctional immuno-oncology therapies for solid tumors. This designation marks a key regulatory milestone for its lead asset, positioning the company to potentially bring a new treatment option to patients facing advanced head and neck cancer.
Bicara Therapeutics stock price
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