Bicara Therapeutics Inc. (BCAX) announced the FDA has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for the first line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma whose tumors express programmed death-ligand 1 with combined positive score 1, excluding human papillomavirus-positive oropharyngeal squamous cell carcinoma.
Claire Mazumdar, Chief Executive Officer of Bicara Therapeutics, said: "We look forward to working closely with the FDA to bring this therapy to patients as quickly as possible."
Shares of Bicara are up 15% in pre-market trade on Monday.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.