Novo Nordisk, Eli Lilly fall after Trump comments on weight loss drug pricing
Investing.com -- Bicara Therapeutics Inc. (NASDAQ:BCAX) stock surged 9.4% in Monday premarket trading after the company announced that its cancer treatment ficerafusp alfa received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration.
The BTD was granted for ficerafusp alfa in combination with pembrolizumab for first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1, excluding human papillomavirus (HPV)-positive cases.
The FDA designation was supported by Phase 1/1b dose cohort results evaluating the drug combination in patients with HPV-negative HNSCC. Data 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, 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 designation is designed to expedite development and review of potential new medicines that demonstrate substantial improvement over existing therapies for serious conditions. It provides Bicara with increased FDA interaction, senior agency leadership involvement, and eligibility for rolling and priority review.
Bicara is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.